Evaluating a new valve system for chronic venous insufficiency
Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency
This study is testing a new valve system to see if it can safely help people with chronic venous insufficiency by improving blood flow in their legs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | InnoVein Industry-sponsored |
| Locations | 3 sites (Nedlands, Western Australia and 2 other locations) |
| Trial ID | NCT04253301 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to assess the safety of the InnoVein Valve and Delivery System in treating chronic venous insufficiency, a condition where ineffective venous valves lead to blood pooling in the legs. The study focuses on patients with symptomatic non-obstructive chronic valvular insufficiency of the femoral vein. Participants will receive the investigational biocompatible valve, which is designed to restore natural blood flow. The study will monitor safety outcomes related to the valve's implantation and functionality.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with symptomatic non-obstructive chronic valvular insufficiency of the femoral vein who can provide informed consent.
Not a fit: Patients with a history of multiple deep vein thromboses or those with inadequate venous inflow or outflow may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve quality of life for patients suffering from chronic venous insufficiency.
How similar studies have performed: While this approach is novel, similar studies evaluating valve implantation for venous insufficiency have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Willing and able to provide written Informed Consent * Diagnosis of symptomatic non-obstructive chronic valvular insufficiency of the femoral vein * Willing and medically able to receive intraprocedural and post-procedural anticoagulation medication * Life expectancy \>1yr * Reflux time \>1s in the superficial femoral and/or popliteal vein Key Exclusion Criteria: * Any prior deep vein intervention within 6 months prior to the Index Procedure * History of 2+ DVTs * Inadequate inflow to the femoral vein or inadequate outflow through the femoral vein, iliac vein, or IVC * Current IVC Placement * History of pulmonary embolism within 6 months * Conditions that increase the risk of device thrombosis or patient bleeding * Any planned surgical or interventional procedure within 30 days prior to or after the Index Procedure * Investigator or sponsor believes the subject would not benefit, would not be appropriate, be unable to follow-up, or be at high risk for non-compliance with the protocol
Where this trial is running
Nedlands, Western Australia and 2 other locations
- Hollywood Private Hospital — Nedlands, Western Australia, Australia (Recruiting)
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Recruiting)
- Flinders — Adelaide, Australia (Recruiting)
Study contacts
- Study coordinator: InnoVen Data Management
- Email: IM-CP-2001@innoveinmedical.com
- Phone: 650-302-0847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.