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8110 Gatehouse Road, Falls Church, VA 22042

Chronic Venous Thrombosis: Relief with Adjunctive Catheter-directed Therapy (C-TRACT)

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT03250247

Background Information

C-TRACT is a large, well-designed study of new treatments for vein damage caused by blood clots. The goal of the study is to understand whether new image-guided procedures (endovascular therapy or EVT) reduce the severity of Post-Thrombotic Syndrome (PTS) and improve quality of life. The long-term safety and costs of the EVT procedure(s) will also be considered. Volunteers will be randomly assigned (like the flip of a coin) to either high quality PTS care (lifestyle interventions, compression therapy, and medical therapy) or high quality PTS care AND endovascular therapy (stent placement to re-open blocked veins and, if needed, endovenous ablation to eliminate backflow in veins with leaky valves). After randomization, patients will be asked to return to their clinical research center for study visits at 2 Months, 4 Months, 6 Months, 12 Months, 18 Months, and 24 Months.

Offered At

Inova Alexandria Hospital
4320 Seminary Road
Alexandria, VA 22304

Eligibility Information

The C-TRACT Trial is actively recruiting volunteers. To meet the goals of the study, we need to enroll and follow 374 patients with moderate-to-severe PTS and blockage of the large veins draining the leg. We are looking for patients who meet the following criteria:

  • ≥ 18 years of age or older
  • Have been diagnosed with a blood clot (Deep Vein Thrombosis/DVT) in the leg in the past (more than 3 months ago)?
  • Currently have Post-thrombotic syndrome of at least moderate severity. Symptoms may include leg heaviness, fatigue, swelling, aching, and/or pain.
  • Suspicion for, or documentation of, iliac vein obstruction (complete or partial)