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
Paper source
Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial.
This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026
How this rating was calculated▸
- IntegrityIntegrity concern−0.5★
- ReportingKey resources not met−0.5★
- ReportingData & code availability not met−0.5★
- ReportingEthical approvals partially met−0.25★
- Data and code not shared
- Key resources not identified
- Ethics/consent reporting incomplete
- Internal contradictions in the reported numbers
This Adcurare Rigor Review uses AI 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.
This clinically important multicenter RCT is methodologically strong in its design (randomization, blinding, power analysis) and clearly motivated by prior evidence. However, it has several pre-submission gaps: no data availability statement, incomplete identification of investigational stents and software, missing CONSORT adherence, and a small arithmetic inconsistency in the safety results. These issues are correctable and should not require new analyses.
Evaluated as an interventional human clinical trial. Some checklist sub-criteria were N/A (e.g., animal housing, cell lines). The statistics verification checked 2 tests, all consistent, but coverage is limited to tests with full reported statistics; the arithmetic inconsistency in bleeding percentages was flagged by this reviewer's synthesis. All eight dimensions were assessed by three independent reviewers; their judgments were reconciled by weighing the combined evidence.
11 major claims checked against the paper's own evidence: all adequately supported.
Recomputed 2 tests: 2 consistent, 0 inconsistent, 2 via agent-written checks.
1 integrity concern flagged (0 high).
8 copyedit issues flagged: mostly consistency, clarity, other.
Checked 40 references: 32 verified — 8 not checked.
1 data/code link checked; 1 live.
Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.
Not ready in its current form. The manuscript requires a data availability statement, identification of investigational products and software (can be in a supplement), addition of race/ethnicity to Table 1, a CONSORT checklist, explicit regulatory compliance language, and correction of the bleeding percentage arithmetic. These are minor reporting fixes that should take less than a day to complete. After these corrections, the paper is ready for submission.
- 1.HIGHdata codeAdd a data availability statement to the Methods or end-matter specifying that de-identified participant data can be accessed through a managed-access process (e.g., NHLBI BioLINCC or via the corresponding author with a data-sharing agreement).ClinicalTrials.gov requires a data sharing statement; without one, the manuscript will be returned.
- 2.HIGHrigorCorrect the internal arithmetic inconsistency in the safety results: verify and report exact counts and denominators for major bleeds (4/112 = 3.6%), non-major bleeds, and total bleeds so that the percentages sum consistently.A demonstrable arithmetic error undermines trust in the reported safety data and will be caught by editors/reviewers.
- 3.HIGHrigorSpecify the statistical software used for all analyses (e.g., SAS 9.4, R 4.2, Stata 17) with version number and vendor in the Statistical Analysis section.Reproducibility requires knowing which software and version produced the results; this is standard for clinical trial reporting.
- 4.HIGHrigorIdentify the investigational venous stents by manufacturer, brand, model, and catalog number; if multiple types were used, list them in a supplemental table. Also name the specific anti-thrombotic drugs (e.g., warfarin, apixaban) and doses.The trial evaluates a device; incomplete identification of the investigational product prevents replication and appropriate regulatory review.
- 5.HIGHreportingReference the CONSORT reporting guideline in the Methods section and submit the completed CONSORT checklist as supplementary material.CONSORT adherence is a standard expectation for RCT publication; its absence will be flagged by the journal.
- 6.HIGHreportingAdd race/ethnicity data to the baseline characteristics table (Table 1), or state explicitly if it was not collected and explain why.Race/ethnicity is a standard demographic variable for human clinical trials and is expected by journals for generalizability assessment.
- 7.HIGHethicsAdd a statement such as 'The trial was conducted in accordance with the Declaration of Helsinki and ICH-GCP guidelines' to the Study Organization section of the Methods.Explicit regulatory compliance is required by most journals; an implied statement is insufficient for the ethics criterion.
- 8.MEDIUMreportingVerify that exact p-values are reported for all secondary outcomes, not just p<0.001 thresholds; provide p-values to 2-3 significant figures where possible.P-value thresholds like 'p<0.001' are less informative than exact p-values and may be considered insufficiently precise.
- 9.MEDIUMcopyeditClarify the denominator '102/102' for stent deployment success: specify that 102 of the 113 patients in the EVT group underwent the procedure, and that 98 had successful deployment and 4 could not be crossed.The current phrasing is ambiguous and may confuse readers about the patient flow.
- 10.MEDIUMcopyeditIn the Sample Size section, clarify that the revised target of 250 refers to total participants (not per group) to avoid misinterpretation.Ambiguous phrasing in a critical method detail can confuse readers about study planning.
- 11.MEDIUMcopyeditRephrase the parenthetical list in 'with missing VCSS values imputed using multiple imputation (MI) (age, sex, body mass index [BMI], strata, baseline VCSS, 6-month Villalta score)' for grammatical clarity, placing the variable list immediately after 'multiple imputation'.The current placement is grammatically awkward and may mislead readers about the imputation model structure.
- 12.LOWcopyeditCheck journal style for capitalization of 'Post-Thrombotic Syndrome' and 'post-thrombotic syndrome' in the title and abstract to ensure consistency.Stylistic inconsistency is a minor issue that copyeditors will flag.
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