Deep Vein Thrombosis Clinical Trial
Official title:
Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis A Prospective, Multicentre Cohort Trial A Physician Initiated Research Study Request
The goal of this initial proof of principle single arm cohort trial is to determine if contemporary endovascular venous intervention, compared with a 1:1 propensity-matched medical therapy arm of the ATTRACT trial, significantly reduces the 2-year occurrence of Post Thrombotic Syndrome (PTS) in subjects with symptomatic proximal Deep Vein Thrombosis (DVT).
A single arm cohort will serve as a proof of principle study, and be the foundation for a
larger subsequent prospective, Randomised Clinical Trial (RCT). The aim of this initial
single arm cohort is to both validate that contemporary catheter directed therapy performed
by experienced operators has significant efficacy and safety at 10 days, 30 days, 6 months,
12 months, and 2 years (details below). If a strong signal of efficacy and safety is found in
the initial single arm cohort at 30 days and 6 months, this will provide objective evidence
to move forward with a larger multicentre, prospective, RCT.
If the results of the initial single arm proof of principle cohort do not show efficacy, or
there is a safety issue, a larger prospective, RCT will not be performed.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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