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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Venous Insufficiency of Leg
• Intervention / Treatment: Device: Cook® Venous Valve System

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia, Colombia
    • Angiosur S.A.S.
  • Barranquilla, Colombia
    • Clinica de la Costa S.A.S.
  • Santander, Colombia
    • Fundacion Oftalmologica De Santander

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Limited inclusion criteria:

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

Limited exclusion criteria:

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
• Positive coronavirus (COVID-19) test six days prior to implant procedure

Anatomical:

• Inability to clearly visualize target implantation site
• Tortuous target implantation site
• Inadequate inflow and/or outflow to the target region

Procedural:

• Inability to gain access to the access site vein
• Untreated focal or diffuse stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cook® Venous Valve System	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from MAE at three months, six months, and 12 months	The secondary safety endpoint is freedom from MAE at three months, six months, and 12 months.	Three months, six months, and 12 months after enrollment

Collaborators and Investigators

• Sponsor: MED Institute Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): September 23, 2023
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 21-4344

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes