Contemporary Endovascular Therapies in Treatment of Acute Iliofemoral Deep Vein Thrombosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deep Vein Thrombosis
- THROMBOLYSIS
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 16 years and 75 years
- Gender
- Both males and females
Description
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 s...
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.
Tracking Information
- NCT #
- NCT03901872
- Collaborators
- Not Provided
- Investigators
- Not Provided
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