Study of the enVVe Vein Valve System for Deep Vein Reflux
Part of Brain & nervous system, Eyes & vision clinical trials.
This trial tests an investigational device called the enVVe System to treat leg symptoms caused by damaged vein valves deep in the leg. If you have persistent leg pain, swelling, or skin changes despite using compression stockings, this study might help you. The device is placed into the vein to improve blood flow back to the heart.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 18 years or older
- You have leg symptoms (like pain, swelling, or skin changes) that have not improved after at least 3 months of standard care (such as compression stockings or wound care)
- Tests show your deep leg veins have faulty valves that let blood flow backward (reflux), usually lasting more than 1 second on an ultrasound
- Your vein size is between 7.5 and 11.5 millimeters in the area to be treated, and your popliteal vein (behind the knee) is at least 4.7 millimeters wide
- You can stand for an ultrasound and walk normally without help
- Your body mass index (BMI) is under 40
- You are willing to follow the study's follow-up schedule and take blood thinners as required
- You do not have certain health conditions like active cancer, a recent blood clot, or a bleeding disorder
- You are not pregnant or breastfeeding, and agree to use birth control if you could become pregnant
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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