Cook Venous Valve System for Treatment of Chronic Venous Insufficiency
NCT05883943 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-05-19
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
- 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.
Sponsors & Collaborators
-
MED Institute Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-24
- Primary Completion
- 2023-09-23
- Completion
- 2028-09-30
- FDA Device
- Yes
Countries
- Colombia
Study Locations
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