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Kaimen Rigor review

Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial.

Vedantham S, Kahn SR, Marston WA, Weinberg I, Sista AK, Magnuson EA, Cohen DJ, Wasan SM, Razavi MK, Goldhaber SZ, Sanfilippo KM, Comerota AJ, Azene EM, Chaar CIO, Leung DA, Kolli KP, Kalva SP, Rostambeigi N, Desai A, Desai KR, Tafur AJ, Khalsa B, Majerus E, Wang B, Wang Y, Nieters P, Derfler MC, Oliver A, Hardy C, Bashir R, Winokur R, Weger N, Khaja MS, Sharma A, Mani N, Kavali P, Thukral S, Lake LL, Mikkelsen K, Parpia S, C-TRACT Trial Investigators

DOI: 10.1056/NEJMoa2519001
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-21

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/202de8cf-7799-4fb0-b653-1aff713d062f is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

3.25 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ReportingKey resources not met−0.5★
ReportingData & code availability not met−0.5★
ReportingEthical approvals partially met−0.25★

Model-reported confidence: highReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Key resources not identified
highDisclosurereviewer-assessedFull detail
The investigational device (stents) is adequately identified, but the anti-thrombotic medications are not fully specified, and no statistical software is identified. This results in a fail for this dimension.
“After EVT, absent contraindications, therapeutic anticoagulation and daily aspirin (81 mg) were recommended for at least 6 months.”
MethodsFind in source
02Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present, and no data or code repositories are mentioned. This is a critical omission for a clinical trial.

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 304DisclosureReporting gaps 05AvailabilityNone found 06Copyedit1 minor suggestion

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

The paper reports a well-conducted multicenter RCT with clear scientific premise, rigorous design, and adequate statistical reporting. However, critical gaps exist in data availability (no data access statement), key resource reporting (incomplete drug specification and missing statistical software), and ethical approval documentation (unnamed IRB, no regulatory compliance statement). A minor copyedit error (inconsistent percentage in Table 3) should also be corrected.

Eight dimensions were evaluated; all were applicable. Two independent reviewers from the same model were synthesized; minor disagreements on key resources (warn vs. fail) were resolved by weighing evidence, leading to a fail. The statistical check covered 7 tests (all consistent) but cannot verify all reported analyses. The copyedit identified one typographical error.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .001 · recomputed p = .001Reviewers 1, 2
Primary outcome VCSS: adjusted difference -2.0, 95% CI -3.2 to -0.8, p=0.001
“VCSS: adjusted difference −2.0, 95% CI −3.2 to −0.8, p=0.001”
Find in source
Taken as given: The adjusted difference is the estimate from the linear mixed model.; The CI is two-sided at 95%.; The p-value is derived from the Wald test of the treatment effect.
Method: p from CI using normal approximation.
How we recomputed it: pCI(-2.0, -3.2, -0.8, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Secondary outcome VEINES-QOL: adjusted difference 14.5, 95% CI 9.5 to 19.4, p<0.001
“VEINES-QOL: adjusted difference 14.5, 95% CI 9.5 to 19.4, p<0.001”
Find in source
Taken as given: The adjusted difference is the estimate from the linear mixed model.; The CI is two-sided at 95%.; The p-value is derived from the Wald test of the treatment effect.
Method: p from CI using normal approximation.
How we recomputed it: pCI(14.5, 9.5, 19.4, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 1
Secondary outcome SF-36 PCS: adjusted difference 6.1, 95% CI 2.8 to 9.3, p<0.001
“SF-36 PCS: adjusted difference 6.1, 95% CI 2.8 to 9.3, p<0.001”
Find in source
Taken as given: The adjusted difference is the estimate from the linear mixed model.; The CI is two-sided at 95%.; The p-value is derived from the Wald test of the treatment effect.
Method: p from CI using normal approximation.
How we recomputed it: pCI(6.1, 2.8, 9.3, 0)
CONSISTENTreported p = .030 · recomputed p = .037Reviewer 1
Safety outcome all bleeding: risk ratio 3.22, 95% CI 1.07 to 9.69, p=0.03
“All bleeding: 13 (11.6%) ... 4 (3.6%) ... 3.22 ... 1.07, 9.69 ... 0.03”
Find in source
Taken as given: The risk ratio is the estimate from the CMH test.; The CI is two-sided at 95%.; The p-value is derived from the Wald test on the log risk ratio.
Method: p from CI using normal approximation on log scale.
How we recomputed it: pCI(3.22, 1.07, 9.69, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Verify the p-value for the VEINES-QOL adjusted difference using the reported 95% CI.
“VEINES-QOL | 62.8 (24.6) | 48.6 (26.7) | 14.5 | 9.5, 19.4 | <0.001”
Find in source
Taken as given: The 95% CI is symmetric on the linear scale.; The CI is two-sided at 95%.; The adjusted difference is 14.5 and the CI is 9.5 to 19.4.; The p-value is from the same model as the CI.
Method: pCI from estimate and confidence interval (two-tailed, normal approximation, log=0).
How we recomputed it: pCI(14.5, 9.5, 19.4, 0)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Verify the p-value for the SF-36 PCS adjusted difference using the reported 95% CI.
“SF-36 PCS | 56.0 (16.4) | 49.9 (17.1) | 6.1 | 2.8, 9.3 | <0.001”
Find in source
Taken as given: The 95% CI is symmetric on the linear scale.; The CI is two-sided at 95%.; The adjusted difference is 6.1 and the CI is 2.8 to 9.3.; The p-value is from the same model as the CI.
Method: pCI from estimate and confidence interval (two-tailed, normal approximation, log=0).
How we recomputed it: pCI(6.1, 2.8, 9.3, 0)
CONSISTENTreported p = .030 · recomputed p = .037Reviewer 2
Verify the p-value for all bleeding (risk ratio) using the reported 95% CI.
“All bleeding | 13 (11.6%) | 4 (3.6%) | 3.22 | 1.07, 9.69 | 0.03”
Find in source
Taken as given: The 95% CI is for the risk ratio from a CMH test.; The CI is two-sided at 95%.; The risk ratio is 3.22 and the CI is 1.07 to 9.69.; The p-value is from the same model as the CI.
Method: pCI from estimate and confidence interval (two-tailed, log-normal approximation, log=1).
How we recomputed it: pCI(3.22, 1.07, 9.69, 1)

lowinternal contradiction
In Table 3, the persistent ulcer count for No-EVT is 10 but the percentage is given as 12.2%, which is inconsistent with 10/112 = 8.9%. This appears to be a typographical error.
Persistent ulcer: 6 (5.4%), 10 (12.2)
Table 3reviewer’s wording

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

8 major claims checked against the paper's own evidence: all adequately supported.

supportedReviewer 1
Endovascular therapy reduces PTS severity at 6 months compared to standard care alone.
The primary outcome (VCSS at 6 months) shows a statistically significant adjusted difference of -2.0 points (95% CI -3.2 to -0.8, p=0.001), supporting the claim.
Evidence: Table 3: VCSS mean 8.1 (5.1) EVT vs 10.0 (4.9) No-EVT; adjusted difference -2.0, 95% CI -3.2 to -0.8, p=0.001.
PTS severity at 6 months was significantly lower in the EVT group than the No-EVT group (mean VCSS score 8.1 [SD 5.1] points EVT versus 10.0 [SD 4.9] points No-EVT, adjusted difference −2.0 points, 95% CI −3.2 to −0.8, p=0.001).
Resultsreviewer’s wording
supportedReviewer 1
Endovascular therapy improves health-related quality of life at 6 months.
Secondary outcomes VEINES-QOL and SF-36 PCS show statistically significant improvements (p<0.001) with clinically meaningful differences, supporting the claim.
Evidence: Table 3: VEINES-QOL adjusted difference 14.5 (95% CI 9.5 to 19.4, p<0.001); SF-36 PCS adjusted difference 6.1 (95% CI 2.8 to 9.3, p<0.001).
At 6 months, the mean VEINES-QOL score was 62.8 (SD 24.6) points for EVT versus 48.6 (SD 26.7) points for No-EVT (adjusted difference 14.5 points, 95% CI 9.5 to 19.4, p<0.001). The mean SF-36 PCS score was 56.0 (SD 16.4) points for EVT versus 49.9 (SD 17.1) points for No-EVT (adjusted difference 6.1 points, 95% CI 2.8 to 9.3, p<0.001).
Resultsreviewer’s wording
supportedReviewer 1
Endovascular therapy leads to a higher risk of bleeding.
Safety outcomes show a significantly higher incidence of all bleeding in the EVT group (11.6% vs 3.6%, p=0.03), supporting the claim.
Evidence: Table 3: All bleeding 13 (11.6%) EVT vs 4 (3.6%) No-EVT; risk ratio 3.22, 95% CI 1.07 to 9.69, p=0.03.
Bleeding (major + non-major) was more frequent in the EVT group (11.6%) than the No-EVT group (3.6%), driven mainly by non-major bleeds (9.8% versus 2.7%).
Resultsreviewer’s wording
supportedReviewer 1
The findings confirm previous single-center studies in a larger multicenter trial.
The Discussion compares the results to prior single-center RCTs and notes that C-TRACT confirms their findings with a larger sample and multisite involvement.
Evidence: Discussion paragraph: 'C-TRACT confirms these findings in a larger study with broad multisite involvement, precautions against bias, and focus on PTS.'
“C-TRACT confirms these findings in a larger study with broad multisite involvement, precautions against bias, and focus on PTS (versus mixed venous disease in earlier trials).”
Discussion ¶1Find in source
supportedReviewer 2
In patients with moderate-or-severe PTS and iliac vein obstruction, EVT reduces PTS severity at 6 months.
The primary outcome (VCSS) shows a statistically significant adjusted difference of -2.0 points (95% CI -3.2 to -0.8, p=0.001), supporting the claim.
Evidence: Table 3: VCSS mean 8.1 (SD 5.1) EVT vs 10.0 (SD 4.9) No-EVT, adjusted difference -2.0, 95% CI -3.2 to -0.8, p=0.001.
“VCSS | 8.1 (5.1) | 10.0 (4.9) | −2.0 | −3.2, −0.8 | 0.001”
Table 3Find in source
supportedReviewer 2
EVT improves venous disease-specific quality of life at 6 months.
The VEINES-QOL score shows a statistically significant adjusted difference of 14.5 points (95% CI 9.5 to 19.4, p<0.001), supporting the claim.
Evidence: Table 3: VEINES-QOL mean 62.8 (SD 24.6) EVT vs 48.6 (SD 26.7) No-EVT, adjusted difference 14.5, 95% CI 9.5 to 19.4, p<0.001.
“VEINES-QOL | 62.8 (24.6) | 48.6 (26.7) | 14.5 | 9.5, 19.4 | <0.001”
Table 3Find in source
supportedReviewer 2
EVT improves generic physical quality of life at 6 months.
The SF-36 PCS shows a statistically significant adjusted difference of 6.1 points (95% CI 2.8 to 9.3, p<0.001), supporting the claim.
Evidence: Table 3: SF-36 PCS mean 56.0 (SD 16.4) EVT vs 49.9 (SD 17.1) No-EVT, adjusted difference 6.1, 95% CI 2.8 to 9.3, p<0.001.
“SF-36 PCS | 56.0 (16.4) | 49.9 (17.1) | 6.1 | 2.8, 9.3 | <0.001”
Table 3Find in source
supportedReviewer 2
EVT leads to a higher risk of bleeding.
The incidence of all bleeding is higher in the EVT group (11.6% vs 3.6%, risk ratio 3.22, 95% CI 1.07 to 9.69, p=0.03), supporting the claim.
Evidence: Table 3: All bleeding 13 (11.6%) EVT vs 4 (3.6%) No-EVT, risk ratio 3.22, 95% CI 1.07 to 9.69, p=0.03.
“All bleeding | 13 (11.6%) | 4 (3.6%) | 3.22 | 1.07, 9.69 | 0.03”
Table 3Find in source

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

ADEQUATESurrogate endpoint
The primary endpoint is the Venous Clinical Severity Score (VCSS), a validated clinical severity scale for chronic venous disease, not a lab biomarker or imaging surrogate. The paper also uses validated patient-reported QOL measures (VEINES-QOL, SF-36) with established minimal clinically important differences. Target engagement is demonstrated by procedural success (96% stent deployment, reduction in obstruction on IVUS/venography). The VCSS is a clinical outcome measure, not a surrogate.
“The primary outcome was PTS severity at 6 months post-randomization, assessed with the VCSS by a clinician who was blinded to treatment arm allocation. The VCSS is a validated scoring system designed to assess clinical change in patients with chronic venous diseases.”
Find in source
ADEQUATEEffect size
The primary effect is a 2.0-point adjusted difference in VCSS (8.1 vs 10.0, p=0.001). The paper acknowledges that the minimal clinically important difference for VCSS is not formally established but notes that the 2-point difference is half the published threshold for incremental clinical severity categories. The QOL improvements (VEINES-QOL 14.5 points, SF-36 PCS 6.1 points) exceed established minimal clinically important differences (4-6 and 2.5 points respectively). The effect is statistically supported and anchored to clinical meaningfulness via QOL measures and severity category shifts.
“While the observed mean VCSS difference is of modest size, many patients shifted to lower severity categories on the PTS scales, indicative of reduced life interference from venous disease. The 14.5-point improvement in venous QOL exceeds the change observed for catheter intervention in acute iliofemoral DVT, and the 6.1-point improvement in SF-36 PCS compares favorably to beneficial interventions in other conditions.”
Find in source

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

3 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data and code not sharedAssessed
Key resources not identifiedAssessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions5 pass · 1 warn · 2 fail

The introduction cites previous studies suggesting benefit of stenting, notes that benefits and risks have not been evaluated in a multicenter RCT, and provides a logical rationale for the trial. The limitation of prior work (lack of multicenter RCT) is directly addressed by the trial design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific premise by citing prior studies and identifying the gap in evidence.

Evidence

paraphrase[Introduction, paragraph 2]

“Previous studies suggest that image-guided endovascular placement of metallic stents may reduce iliofemoral venous obstruction and thereby improve venous physiology, PTS severity, and QOL. However, its benefits and risks have not been evaluated in a multicenter randomized controlled trial.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research, providing a logical rationale for the study, and addressing limitations of prior work.

Evidence

paraphrase[Introduction, paragraph 3]

“We therefore conducted the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy (C-TRACT) Trial to determine if endovascular therapy (EVT) reduces PTS severity.”

Introduction ¶3Find in source

“C-TRACT confirms these findings in a larger study with broad multisite involvement, precautions against bias, and focus on PTS (versus mixed venous disease in earlier trials).”

Discussion ¶1Find in source

Randomization was web-based with concealed allocation. Blinding of assessors and core lab readers was described. Sample size calculation was provided with alpha, power, and anticipated effect. Inclusion/exclusion criteria were specified. Modified ITT and multiple imputation addressed missing data, satisfying the outlier handling mapping.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design is rigorous with central randomization, blinding of outcome assessors, a priori power analysis, and clear inclusion/exclusion criteria.

Evidence

“Patients were allocated 1:1 to receive EVT (iliac vein stent placement and enhanced anti-thrombotic therapy) or No-EVT using web-based central randomization.”

MethodsFind in source

paraphrase[Methods, Outcome Assessments]

“The primary outcome was PTS severity at 6 months post-randomization, assessed with the VCSS by a clinician who was blinded to treatment arm allocation.”

“With α=0.05 (two-sided) and 90% power to detect a 2-point difference, 155 patients per group were required.”

MethodsFind in source

PASSReviewer 2· 95% conf

The study design is rigorous: randomization, blinding, power analysis, inclusion/exclusion criteria, and missing data handling are all adequately reported.

Evidence

paraphrase[Methods, Stratification and Randomization]

“Patients were allocated 1:1 to receive EVT (iliac vein stent placement and enhanced anti-thrombotic therapy) or No-EVT using web-based central randomization. Randomization was stratified by clinical center... The randomization sequence, computer-generated in advance by an independent statistician using varying block sizes, was not accessible to clinical center personnel.”

paraphrase[Methods, Outcome Assessments]

“The primary outcome was PTS severity at 6 months post-randomization, assessed with the VCSS by a clinician who was blinded to treatment arm allocation.”

paraphrase[Methods, Sample Size]

“With α=0.05 (two-sided) and 90% power to detect a 2-point difference, 155 patients per group were required. ... the target sample size was increased by 20.6% to 374 (187 per group).”

Table 1 reports age, sex, race, ethnicity, BMI, CEAP class, VCSS, and other clinical variables. Both sexes are included, so sex justification is not applicable. Weight is reported as BMI, which is a standard proxy.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Demographics, sex, age, BMI, and clinical characteristics are well-reported in Table 1.

Evidence

paraphrase[Table 1]

“Age (years): mean (SD) 56.1 (12.7) ... Sex - Female: n (%) 52 (46.4%)”

paraphrase[Table 1]

“Race: Black 31 (27.7%), White 73 (65.2%), Other 2 (1.8%); Ethnicity - Hispanic or Latino: 12 (10.7%); BMI (kg/m2): mean (SD) 35.0 (8.3)”

PASSReviewer 2· 80% conf

Sex and demographics are reported; age and health status are reported, but weight is not directly reported (BMI is used instead). This is a minor omission but does not affect the overall pass.

Evidence

“Sex - Female: n (%) | 52 (46.4%) | 54 (48.2%)”

Table 1Find in source

paraphrase[Table 1]

“Age (years): mean (SD) | 56.1 (12.7) | 54.4 (14.2) | BMI (kg/m2): mean (SD) | 35.0 (8.3) | 35.3 (8.3)”

paraphrase[Table 1]

“Race: n (%) | Black | 31 (27.7%) | 23 (20.5%) | Other | 2 (1.8%) | 3 (2.7%) | White | 73 (65.2%) | 78 (69.6%) | Ethnicity - Hispanic or Latino: n (%) | 12 (10.7%) | 15 (13.4%)”

The paper reports 'The study was approved by a central institutional review board' and 'all patients provided informed consent.' However, the IRB is not named, which is considered inadequate per the criteria. No statement of compliance with the Declaration of Helsinki or other regulatory framework is provided. This is a fixable reporting gap, so 'warn' is appropriate.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

IRB approval and informed consent are reported, but compliance with a recognized regulatory framework (e.g., Declaration of Helsinki) is not explicitly stated.

Evidence

“The study was approved by a central institutional review board; all patients provided informed consent.”

MethodsFind in source

WARNReviewer 2· 90% conf

The study states ethics approval by a central IRB and informed consent, but does not name the IRB explicitly and does not mention regulatory compliance (e.g., Declaration of Helsinki).

Evidence

“The study was approved by a central institutional review board; all patients provided informed consent.”

MethodsFind in source

absence[Methods, Study Organization]

Regulatory compliance is not stated.

Stents are identified by brand and manufacturer in Table 2. Aspirin 81 mg is recommended, but other anticoagulant drugs are not named. The statistical software used for analysis is not mentioned. For a drug/device trial, the investigational product is a scored resource, and the software is applicable. Only one of two applicable sub-criteria is partially met (reagents_identified is inadequate due to incomplete drug specification; software_tools_identified is not reported).

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

The investigational product (stent types and manufacturer) is well-described, but the statistical software used is not identified.

Evidence

paraphrase[Table 2]

“Abre (Medtronic), SMART (Cordis), Venovo (Becton Dickinson), Vici (Boston Scientific), WallStent (Boston Scientific), Zilver Vena (Cook Medical)”

absence[Methods, Statistical Analysis]

No statistical software identified.

FAILReviewer 2· 85% conf

The investigational device (stents) is adequately identified, but the anti-thrombotic medications are not fully specified, and no statistical software is identified. This results in a fail for this dimension.

Evidence

paraphrase[Table 2]

“Type of stent: n | Abre (Medtronic) | 81 | SMART (Cordis) | 13 | Venovo (Becton Dickinson) | 53”

“After EVT, absent contraindications, therapeutic anticoagulation and daily aspirin (81 mg) were recommended for at least 6 months.”

MethodsFind in source

absence[Methods, Statistical Analysis]

Statistical software is not identified.

Tests are named (linear mixed model, CMH test), assumptions are handled by the analysis model (linear mixed model), exact p-values are given, effect sizes with 95% CIs are reported, and data presentation includes per-group means and SDs. Software is not reported, but this does not affect the majority of criteria. Mathematical plausibility checks did not reveal errors.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The statistical methods are clearly described, exact p-values and effect sizes with CIs are reported, and data presentation is adequate.

Evidence

paraphrase[Table 3]

“VCSS: adjusted difference −2.0, 95% CI −3.2 to −0.8, p=0.001”

paraphrase[Methods, Statistical Analysis]

“The primary efficacy analysis was the comparison between groups of the mean 6-month VCSS using the modified ITT population and a linear mixed model... ”

PASSReviewer 2· 90% conf

Statistical tests are named, exact p-values and effect sizes with CIs are reported, data presentation is adequate, and no arithmetic issues are found. Assumption verification is not explicitly stated but the methods are standard, and software is not identified; these are minor omissions.

Evidence

“The primary efficacy analysis was the comparison between groups of the mean 6-month VCSS using the modified ITT population and a linear mixed model adjusted for baseline VCSS, strata (normal/abnormal CFV, presence/absence of open venous ulcer) as fixed effects, and center as a random effect”

Statistical analysisFind in source

“VCSS | 8.1 (5.1) | 10.0 (4.9) | −2.0 | −3.2, −0.8 | 0.001”

Table 3Find in source

“All bleeding | 13 (11.6%) | 4 (3.6%) | 3.22 | 1.07, 9.69 | 0.03”

Table 3Find in source

The paper includes a trial registration number but does not include a data availability statement, mention of data repository deposit, or code sharing. For a clinical trial, a data availability statement with a concrete access route (even managed access) is required. The absence of any such statement results in a fail.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

FAILReviewer 1· 90% conf

No data availability statement is provided; the paper only includes a trial registration number.

Evidence

absence[Entire manuscript]

No data availability statement.

paraphrase[Abstract]

“Trial Registration: www.clinicaltrials.gov : NCT03250247”

FAILReviewer 2· 95% conf

No data availability statement is present, and no data or code repositories are mentioned. This is a critical omission for a clinical trial.

Evidence

absence[Entire paper]

No data availability statement found.

absence[Entire paper]

No repository deposit or code sharing mentioned.

The paper includes a CONSORT diagram, trial registration number, thorough methods, and a limitations section. The conclusions are proportional to the evidence. The reporting guideline is not explicitly cited, but the essential elements are present.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The manuscript is well-organized with detailed methods, trial registration, funding disclosure, and limitations discussion, though the CONSORT guideline is not explicitly referenced.

Evidence

paraphrase[Abstract]

“Trial Registration: www.clinicaltrials.gov : NCT03250247”

“This study has limitations. To enable quality standard PTS care and reflect real-world practice, the protocol provided guidance but allowed local physician-directed care.”

DiscussionFind in source

PASSReviewer 2· 90% conf

The paper is transparent: methods are detailed, the trial is registered, all outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. Adherence to a reporting guideline is not explicitly stated, but a CONSORT diagram is provided.

Evidence

paraphrase[Abstract, Trial Registration]

“Trial Registration: www.clinicaltrials.gov : NCT03250247”

“This study has limitations. To enable quality standard PTS care and reflect real-world practice, the protocol provided guidance but allowed local physician-directed care.”

Discussion ¶4Find in source

paraphrase[Funding section]

“The C-TRACT trial is sponsored by the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (NIH) via grants UH3-HL138325 ... Disclosure forms provided by the authors are available with the full text of this article at NEJM.org”

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

ClinicalTrials.gov

NCT03250247

Reporting guidelines: CONSORT

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 40 references by DOI: 32 verified — 8 no DOI (shown, not verified).

NO DOI
A clinical trial of venous stent placement for post-thrombotic syndrome: current status and pandemic-related changes
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
American Society of Hematology 2020 guidelines for management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Pentoxifylline for treating venous leg ulcers
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Three-year outcomes of the Abre Venous Self-Expanding Stent System in patients with symptomatic iliofemoral venous outflow obstruction
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
SF-36 physical and mental summary measures: A user's manual
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Determining important differences in scores
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Health measurement scales: A practical guide to their development and use
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Long-term clinical and quality of life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

2 data/code links checked; 1 live.

datahttps://clinicaltrials.gov/ct2/show/NCT03250247LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttp://NEJM.orgUNVERIFIEDHTTP 403
Liveness indeterminate — content not checked.

Copyediting

1 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 1 minor suggestion below.

1 copyedit issue flagged: mostly consistency.

MINORconsistencyTable 3, Persistent ulcer row for No-EVT
“10 (12.2)”
→ 10 (8.9%)
The percentage 12.2% does not match 10/112 = 8.9%; likely a typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is methodologically sound in its core trial design and analysis, but informed readers should weigh the absence of a data availability statement (undermining reproducibility) and the incomplete specification of anti-thrombotic drugs (a replicability concern). The typographical error in Table 3 is minor but warrants a correction. Overall, the paper is robust but would benefit from an erratum addressing the data availability and reporting gaps.

1.
HIGHdata code
Add a data availability statement specifying the conditions for accessing individual participant data (e.g., via a managed-access platform like YODA or Vivli) in the Methods or a dedicated Data Availability section.
For a published clinical trial, the absence of any data access statement is a critical reproducibility gap that readers and funding agencies expect to be addressed.
2.
HIGHcopyedit
Correct the percentage in Table 3, Persistent ulcer row for No-EVT: change '10 (12.2)' to '10 (8.9%)' to match the denominator of 112.
The internal inconsistency (10/112 = 8.9%, not 12.2%) is a verifiable error that undermines trust in the reported data.
3.
HIGHethics
Name the specific institutional review board that approved the study (e.g., 'central IRB at Washington University in St. Louis') and state compliance with the Declaration of Helsinki in the Methods (Study Organization).
Current reporting is vague; explicitly naming the IRB and regulatory framework is standard for ethical transparency.
4.
HIGHreporting
Specify the exact anticoagulant drugs used (e.g., warfarin, rivaroxaban) in the Treatments section rather than the vague 'therapeutic anticoagulation'.
The intervention is not fully replicable without knowing which specific anticoagulants were recommended; this is a key resource gap.
5.
HIGHreporting
Identify the statistical software used (e.g., SAS version 9.4, R version 4.2) in the Statistical Analysis section.
Statistical software identification is a standard reproducibility requirement; its absence was flagged by both reviewers.
6.
MEDIUMreporting
Add a brief note on assumption verification for the linear mixed model (e.g., normality of residuals was checked via Q-Q plots) in the Statistical Analysis section.
While not always required, explicitly stating that assumptions were checked strengthens the statistical reporting.
7.
MEDIUMreporting
Explicitly mention adherence to the CONSORT 2010 reporting guideline in the Methods section, even though a CONSORT diagram is provided.
Explicit guideline declaration is good practice and completes the reporting transparency checklist.

Full text (32,907 chars)Analyzed: Aug 10, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial.

DOI

10.1056/NEJMoa2519001

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-21