Cook Venous Valve System for Treatment of Chronic Venous Insufficiency
- Conditions
- Venous Insufficiency of Leg
- Interventions
- Device: Cook® Venous Valve System
- Registration Number
- NCT05883943
- Lead Sponsor
- MED Institute Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cook® Venous Valve System Cook® Venous Valve System -
- Primary Outcome Measures
Name Time Method Freedom from major adverse events in the first 30 days 30 days after enrollment The primary safety endpoint is freedom from major adverse events (MAE) in the first 30 days, where MAE is defined as: death, clinically-driven reintervention, bleeding requiring transfusion, flow limiting dissection of the target vessel, or clinically significant deep vein thrombosis (DVT), pulmonary embolism, or device migration.
- Secondary Outcome Measures
Name Time Method Freedom from MAE at three months, six months, and 12 months Three months, six months, and 12 months after enrollment The secondary safety endpoint is freedom from MAE at three months, six months, and 12 months.
Trial Locations
- Locations (3)
Clínica de La Costa S.A.S.
🇨🇴Barranquilla, Colombia
Fundacion Oftalmologica De Santander
🇨🇴Santander, Colombia
Angiosur S.A.S.
🇨🇴Antioquia, Colombia