NCT05883943

Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

First-in-Human Early Feasibility Clinical Evaluation of Safety, Efficacy and Utility of the Cook® Venous Valve System for Treatment of Chronic Venous Insufficiency

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: MED Institute Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.

Conditions

• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	Cook® Venous Valve System	The Cook® Venous Valve is a permanent prosthetic, bicuspid, one-way flow valve designed to be percutaneously implanted into the peripheral deep venous system. The Cook® Venous Valve Delivery System is used to percutaneously deliver the Cook® Venous Valve into the deep venous system.

Timeline

• Start date: 2023-04-24
• Primary completion: 2023-09-23
• Completion: 2028-09-01
• First posted: 2023-06-01
• Last updated: 2025-05-20

Locations

3 sites across 1 country: Colombia

Regulatory

• FDA-regulated device study