# 1/2 CATHETER-DIRECTED THERAPY FOR CHRONIC DVT (C-TRACT TRIAL)

> **NIH NIH UH3** · WASHINGTON UNIVERSITY · 2022 · $1,522,853

## Abstract

PROJECT SUMMARY
The post-thrombotic syndrome (PTS) is a permanent complication of lower extremity deep vein thrombosis
(DVT). Patients with moderate-to-severe PTS secondary to chronic iliac vein obstruction experience
profound disability and quality of life impairment from pain, massive edema, stasis dermatitis, and/or venous
leg ulcers ("Disabling Iliac-Obstructive PTS" [DIO-PTS]). Currently, there is no evidence-based therapy for
DIO-PTS. Observational studies and a small single-center randomized trial suggest that imaging-guided,
catheter-based endovascular therapy (EVT) that eliminates iliac vein obstruction (stent placement) and
saphenous venous valvular reflux (endovenous ablation) is effective. However, EVT has risks and is costly.
We therefore plan to do an open-label, assessor-blinded, multicenter, randomized controlled trial (the
Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy (C-TRACT) Study)
that will compare EVT with No-EVT in 374 patients with DIO-PTS. All patients will receive optimal
standardized medical therapy for PTS. The primary outcome will be within-subject improvement in PTS
severity over 6 months, assessed blindly using the Venous Clinical Severity Score (VCSS). Secondary
outcomes include PTS severity (VCSS, Villalta, ulcer healing), and venous disease-specific (VEINES-QOL)
and generic (SF-36) quality of life at 6 and 24 months. A comprehensive health economic analysis will
compare medical costs and estimate the incremental cost-effectiveness of EVT. Safety (e.g. bleeding,
recurrent thrombosis) will be assessed at 2, 6, and 24 months, and venous imaging will be performed to
identify anatomic and physiologic predictors of therapeutic response. The C-TRACT Study will change
clinical practice: if EVT is effective and safe, it will become part of standard therapy for DIO-PTS; if not, a
risky and costly therapy will be avoided. Hence, either study outcome will improve public health and
advance the NHLBI’s mission.

## Key facts

- **NIH application ID:** 10475574
- **Project number:** 5UH3HL138325-05
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** SURESH VEDANTHAM
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,522,853
- **Award type:** 5
- **Project period:** 2017-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10475574

## Citation

> US National Institutes of Health, RePORTER application 10475574, 1/2 CATHETER-DIRECTED THERAPY FOR CHRONIC DVT (C-TRACT TRIAL) (5UH3HL138325-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10475574. Licensed CC0.

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