NCT03250247

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).

Detailed description

The rationale for performing the C-TRACT Trial is based upon: 1. the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon General's 2008 Call to Action on DVT (95); 2. the inability of existing therapies to prevent or alleviate most cases of DIO-PTS; 3. the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS; 4. the ability of stent placement and endovenous ablation to eliminate obstruction and reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies; 5. the risks, costs, and uncertainties of this novel but invasive strategy; 6. the lack of consensus on whether EVT should be used for DIO-PTS; 7. the motivation of our established investigator team to answer this critical clinical question. We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures. 250 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be enrolled over approximately 36 months in 20-40 U.S. Participants enrolled in C-TRACT protocol versions prior to 5.0 will be followed for 24 months. Subjects enrolled on protocol version 5.0 or after will be followed for 6 months. The study will take approximately 6 years to complete.

Conditions

• Deep Vein Thrombosis
• Venous Stasis
• Venous Insufficiency
• Venous Leg Ulcer
• Venous Reflux
• Post Thrombotic Syndrome

Interventions

Type	Name	Description
DEVICE	Stents	US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram and intravascular ultrasound of CFV through infrarenal IVC. Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein. The use of devices \> 14 mm is highly recommended for the iliac vein and should be dilated to at least 14 mm, unless compelling patient factors dictate dilatation to a smaller diameter. Balloon angioplasty of inflow veins if needed to optimize inflow, per standard practice.

Timeline

• Start date: 2018-07-02
• Primary completion: 2025-11-11
• Completion: 2026-04-27
• First posted: 2017-08-15
• Last updated: 2026-01-28

Locations

29 sites across 1 country: United States

Regulatory

• FDA-regulated device study