New artificial vein valve could help millions with leg vein disease

NCT ID NCT07609927

Not yet recruiting Disease control Sponsor: Hancock Jaffe Laboratiores, Inc Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This trial tests a new device called the enVVe system, a catheter-based artificial valve placed in leg veins to treat chronic venous insufficiency. The study will enroll 220 people with severe symptoms like skin changes or leg ulcers. Participants are randomly assigned to receive the valve or standard care, and researchers will measure how well the valve reduces backward blood flow and whether it is safe over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: enVVe system (a catheter-based artificial vein valve)
What this could lead to: If it works, this could offer a new treatment option for people with severe chronic venous insufficiency, potentially reducing leg swelling, pain, and ulcers.
What could go wrong: This is an early-to-mid stage trial with only 220 participants, so results may not apply to everyone. Risks include blood clots, valve infection, or the valve moving out of place.

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Conditions

The condition(s) this trial relates to.

chronic venous insufficiency cortical blindness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC VENOUS INSUFFICIENCY (CVI)

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