Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

NCT05883943 | Active Not Recruiting FDA Device

• 1 other identifier: 21-4344
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Venous Insufficiency of Leg

Outcome Measures

Primary Outcomes (1)

• Freedom from major adverse events in the first 30 days

  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.

  30 days after enrollment

Secondary Outcomes (1)

• Freedom from MAE at three months, six months, and 12 months

  Three months, six months, and 12 months after enrollment

Study Arms (1)

Cook® Venous Valve System

EXPERIMENTAL

Device: Cook® Venous Valve System

Interventions

Cook® Venous Valve System DEVICE

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.

Cook® Venous Valve System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented symptomatic deep venous reflux in one limb
• Deep venous reflux in the region of interest

You may not qualify if:

• General:
• Age \< 18 years
• BMI ≥ 40
• Cultural objections to porcine materials
• Unwillingness or inability to comply with the follow-up
• Unwillingness to provide study data for duration of study
• Simultaneous participation in another device or drug study
• Inability or refusal to give informed consent
• Medical:
• Pregnant, or planning to become pregnant
• Diagnosis of terminal illness with life expectancy less than 12 months
• Complete symptom resolution with compliant compression therapy for three months
• Untreated superficial venous disease
• Medical interventions including any of the following: planned procedure of any leg, vascular intervention or major surgery within the last three months, implanted inferior vena cava filter
• Medical history of any of the following: anticoagulation treatment for pulmonary embolism (within the last six months or ongoing), insulin dependent diabetes, chronic obstructive pulmonary disease, renal dysfunction requiring dialysis, leg amputation, bleeding diathesis, untreated or unresolved systemic infection or local infection, active malignancy except non-melanoma skin cancer, other acute or chronic medical condition that may cause noncompliance with the protocol or confound the study results, documented history of significant untreated stenosis within the arterial system

Sponsors & Collaborators

• MED Institute Inc.: lead

Study Sites (3)

Angiosur S.A.S.

Antioquia, Colombia

Location

Clínica de La Costa S.A.S.

Barranquilla, Colombia

Location

Fundacion Oftalmologica De Santander

Santander, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 1, 2023
• Study Start: April 24, 2023
• Primary Completion: September 23, 2023
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (3)