A Feasibility Study of the ReLeaf Catheter System (ReLeaf)
|ClinicalTrials.gov Identifier: NCT02462096|
Recruitment Status : Terminated (Device modification and simplification of procedural steps)
First Posted : June 3, 2015
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Venous Insufficiency||Device: ReLeaf||Not Applicable|
The ReLeaf catheter system is intended for the creation of tissue leaflets in the deep veins where existing valve structures are no longer healthy and effectively moving blood.
This study aims to treat subjects with a documented history of symptomatic chronic venous insufficiency in whom compression therapy for at least 6 months, combined with superficial venous and/or perforator surgery have failed to obtain clinical improvement.
This clinical trial is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein|
|Actual Study Start Date :||September 9, 2015|
|Actual Primary Completion Date :||October 8, 2016|
|Actual Study Completion Date :||June 5, 2017|
Subject to undergo the ReLeaf study procedure.
The ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs.
Other Name: Tissue Leaflet Creation, Creation of Valve-like Effect
- Technical Feasibility [ Time Frame: Day 0 ]Technical feasibility will be evaluated as the ability of the ReLeaf Catheter System to access the target site and successfully modify tissue as confirmed by, and in the opinion of, the Investigator. Successful target site access and confirmed tissue modification will be used as a measure of technical feasibility.
- Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety) [ Time Frame: Day 30 ]Safety will be evaluated as freedom from serious adverse events directly attributed to the investigational device. The number of SAEs directly attributable to the study device will be used as a measure of safety.
- Efficacy [ Time Frame: Day 365 ]Subsequent efficacy of the treatment following successful creation of the tissue leaflet(s). This will be measured through an assessment of tissue leaflet creation and the tissue leaflets ability to impact blood flow over the course of time.
- Durability [ Time Frame: Day 365 ]Long-term durability of the tissue leaflet(s). Confirmation of tissue leaflet existence over time will be used to assess the durability of the tissue leaflet.
- Long-term Safety (Long-term safety will be measured by freedom from SAEs directly attributable to the study device) [ Time Frame: Day 365 ]Further long-term safety data will be collected, analyzed and reported through the end of the study. Long-term safety will be measured by freedom from SAEs directly attributable to the study device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462096
|Auckland City Hospital|
|Auckland, New Zealand|