Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Launched by INNOVEIN · Jan 31, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the InnoVein Valve and Delivery System to see if it is a safe option for treating a condition known as chronic venous insufficiency. This condition occurs when the veins in the legs are not able to properly return blood to the heart, leading to symptoms like swelling, pain, or discomfort. The study is currently recruiting participants who are between the ages of 65 and 74 and who have been diagnosed with this condition, specifically affecting the femoral vein. To join the trial, individuals must be able to give their consent, have a specific type of vein issue, and be willing to take medication to prevent blood clots during and after the procedure.

Participants in the trial can expect to undergo a procedure that involves using the InnoVein device, which aims to improve blood flow in the affected veins. It’s important to note that there are some criteria that would exclude certain individuals, such as those who have had recent deep vein treatments, a history of multiple blood clots, or certain medical conditions that could increase their risks during the trial. Overall, this study aims to explore a new potential treatment for chronic venous insufficiency, and participants will be closely monitored for safety and effectiveness throughout the process.

Gender

ALL

Eligibility 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