Clinical trial NCT03216005: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Official title: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Venous Insufficiency
Lead sponsor: Intervene, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, non-randomized, multicenter pre-market feasibility study
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
* Failed compression therapy of at least 6 months' duration;
* Deep system venous reflux characterized by \>1 second reflux time;
* Presence of at least one target site within the target vessel.

Exclusion Criteria:

* Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
* Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
* Significant peripheral arterial disease with an ankle-brachial index of \<0.50 or with incompressible vessels;
* Acute deep venous thrombosis (DVT) within 3 months of consent;
* History of stroke within the last 6 months;
* Flow-limiting venous outflow obstruction central to the intended target sites;
* Insufficient inflow through the treatment vein upon manual augmentation;
* Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
* Chronic renal insufficiency with creatinine level of ≥2mg/dL;
* Hemoglobin level \<9.0 mg/dL;
* Platelet count \<50,000 or \>1,000,000 per mm3;
* Total white blood cell count \<3,000/mm3;
* Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
* Non-ambulatory patients;

Primary outcomes:
measure: Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
timeFrame: 30 days
measure: Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales
state: New South Wales
city: Vancouver
country: Canada
facility: Vancouver Coastal Health Research Institute
state: British Columbia
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand Ltd
Study officials:
affiliation: Intervene, Inc.
name: Fletcher Wilson
role: STUDY_DIRECTOR
References: