Clin2
NCT07609927Possibly a fitNot yet recruiting

enVVe Valve System for Severe Leg Vein Disease

Chronic Venous Insufficiency, CVI

Part of Brain & nervous system, Eyes & vision clinical trials.

This trial tests a new implantable valve designed to treat severe leg swelling and skin damage caused by faulty deep veins that have stopped working properly. The valve may help prevent complications and improve symptoms after standard treatments haven't fully worked.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2/Phase 3
Enrollment
220 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • Leg symptoms that haven't improved after at least 3 months of standard care (compression stockings, pneumatic compression, and wound care if needed)
  • Specific vein damage confirmed by ultrasound showing backward blood flow in the deep veins of your thigh and behind your knee
  • Moderate to severe leg swelling, skin changes, or open wounds (CEAP score C4b, C4c, C5, or C6)
  • Able to walk normally without assistance and stand still for imaging tests
  • Able to attend all follow-up visits and take blood-thinning medications for at least 6 months to 5 years after the procedure
  • No recent blood clots, active cancer, or major surgery within the past 2 months

View the official record on ClinicalTrials.gov

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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