Clinical Trials Logo
  1. Home
  2. Chronic Venous Insufficiency
  3. NCT03216005

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System — INFINITE-OUS  

Chronic Venous Insufficiency Clinical Trial

Official title:
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

Clinical Trial Summary

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Clinical Trial Description

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03216005
Study type Interventional
Source Intervene, Inc.
Contact Tracy Roberts
Phone 303-396-4603
Email tracy@intervene-med.com
Status Recruiting
Phase N/A
Start date November 2, 2017
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Terminated NCT02462096 - A Feasibility Study of the ReLeaf Catheter System N/A
Enrolling by invitation NCT05504070 - Venclose digiRF System Post Market Study N/A
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Recruiting NCT05622500 - Best Endovenous Treatment, Including STenting, Versus Non-endovenous Treatment in Chronic Proximal Deep Venous Disease N/A
Completed NCT03283800 - Copper Impact on Venous Insufficiency and Lipodermatosclerosis N/A
Terminated NCT02248740 - Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein Phase 4
Completed NCT02236338 - Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein Phase 4
Completed NCT01501188 - Efficacy Study of Kinesio Taping to Treat Muscular and Joint Problems in Chronic Venous Insufficiency Phase 1
Recruiting NCT05982405 - Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency N/A
Completed NCT05383469 - Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency N/A
Completed NCT06238791 - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Withdrawn NCT02559427 - SPA Therapy in the Treatment of Sleep Apnea Syndrome N/A
Completed NCT02346058 - Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins Phase 4
Recruiting NCT05926830 - Extracorporeal Flow Abolition in Relation With Primary Insufficiency of Great Saphenous Veins (GSV) Using High Intensity Focused Ultrasound (HIFU) Generated by Sonovein: A Multi Center Prospective Pivotal Study N/A
Withdrawn NCT05047302 - Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System-Canada N/A
Active, not recruiting NCT04339075 - Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
Active, not recruiting NCT04580160 - Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System N/A
Not yet recruiting NCT02927483 - Study to Assess the Efficacy and Safety of Endolex Forte VErsus Diosmin and Hesperidin in Reducing VeNous Insufficiency Phase 3
Completed NCT02015221 - Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort N/A
Completed NCT02050061 - Chronic Venous Insufficiency; Impact of Compression Stockings on Quality of Life N/A