Cook Venous Valve System for Treatment of Chronic Venous Insufficiency

Venous Insufficiency of Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05883943
• Other study ID #: 21-4344
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: August 2028

Study information

• Verified date: May 2023
• Source: MED Institute Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4
• Est. completion date: August 2028
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency
• Venous Insufficiency of Leg

Intervention

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.

Locations

Country	Name	City	State
Colombia	Angiosur S.A.S.	Antioquia
Colombia	Clínica de La Costa S.A.S.	Barranquilla
Colombia	Fundacion Oftalmologica De Santander	Santander

Sponsors (1)

Lead Sponsor	Collaborator
MED Institute Inc.

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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