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).
The rationale for performing the C-TRACT Trial is based upon:
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.
374 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. Clinical Centers, and followed for 24 months. The study will take approximately 6 years to complete.
Condition | Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer, Venous Reflux, Post Thrombotic Syndrome |
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Treatment | Stents |
Clinical Study Identifier | NCT03250247 |
Sponsor | Washington University School of Medicine |
Last Modified on | 21 October 2022 |
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