Evaluating a new valve system for chronic venous insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.