Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Venous Insufficiency
- Sponsor
- Intervene, Inc.
- Primary Endpoint
- Change in Venous Clinical Severity Score (VCSS)
- Status
- Withdrawn
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
STUDY DESIGN: The Study is a prospective, non-randomized study to evaluate participants treated with the BlueLeaf System for the restoration of deep venous competence for the treatment of symptomatic chronic venous insufficiency (CVI). STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility. Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints. STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6. STUDY ENROLLMENT: Up to 50 subjects will be enrolled.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older;
- •Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) classification 4 to 6;
- •Failed at least 6 months of conservative therapy at some point during the course of their CVI management (symptoms not adequately resolved or patient non-compliant/unable to tolerate);
- •Willing and able to sign the approved informed consent form (ICF);
- •Willing to comply with follow-up evaluations and protocols;
- •Deep system venous reflux characterized by \>1 second reflux time in two contiguous vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by DUS with patient in the standing position;
- •Presence of at least two potential target sites within the target vessel, which is defined as a segment within the femoral or popliteal vein that is:
- •not less than 7mm in luminal diameter, and
- •not more than 11mm in luminal diameter, and
- •at least 3cm long (two target sites in a row must be spaced at least 1cm apart), and
Exclusion Criteria
- •Untreated significant superficial venous incompetence within 30 days of screening which, in the opinion of the Investigator, may be the primary source of existing symptoms;
- •A competent vein valve in any vein segment through which the device is likely to be inserted, as assessed by DUS (\<1 second reflux time) or with contrast venography (Investigator's opinion);Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent;
- •Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent
- •Significant peripheral arterial disease with an ankle-brachial index of \<0.70 or with incompressible vessels;
- •Contraindications to all protocol specified anticoagulation options;
- •Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication);
- •Acute deep venous thrombosis (DVT) within 6 months of consent;
- •Comorbidity risks or other concerns (e.g. recent cancer) which, in the opinion of the Investigator, limit longevity or likelihood of complying with the protocol and its prescribed follow up or would preclude the patient from open surgery in the event of a complication requiring surgical intervention (e.g. severe vein laceration);
- •General contraindications to local, regional or general anesthesia required for the index procedure;
- •NYHA Class III or IV heart failure;
Outcomes
Primary Outcomes
Change in Venous Clinical Severity Score (VCSS)
Time Frame: 1 year
A decrease in score from baseline