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

Study Overview
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Brief Summary
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Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity

Detailed Description
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The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years.

Official Title
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Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)

Conditions
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Chronic Venous Insufficiency (CVI), Deep Vein Reflux

Intervention / Treatment
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* Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria 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) Deep system venous reflux characterized by >1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is: 7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation). In the Investigator's opinion, the subject is a good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy Key Exclusion Criteria: Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms Acute deep venous thrombosis (DVT) within 1 year of consent Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent Flow-limiting venous outflow obstruction central to the intended target sites, defined by a common femoral vein duplex exam found to have a continuous waveform without respiratory variation Contraindications to all protocol specified anticoagulation options Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication) Women on long-term oral contraceptives Non-ambulatory patients Significant peripheral arterial disease with an ankle-brachial index of < 0.70 or with incompressible vessels New York Heart Association Class III or IV heart failure Patients with a history of right heart failure occurring as a consequence of, for example, biventricular failure, intrinsic pulmonary disease, chronic thromboembolic pulmonary hypertension, and other etiologies that result in elevated right-sided pressures. Active systemic infection Invasive surgical procedure within the last 3 months that in the Investigator's opinion would interfere with the study procedure or results Chronic renal insufficiency with creatinine level of ≥ 2mg/dL Hemoglobin level < 9.0 mg/dL Platelet count < 50,000 or > 1,000,000/mm3 Total white blood cell count < 3,000/mm3 Subject is enrolled in another clinical study that, in the opinion of the Investigator, may c Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol and its prescribed follow up (e.g. recent cancer or stroke); or precludes patient from being transitioned to open surgery if complication requiring surgical intervention occurs during the procedure (such as severe vein laceration).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>Subjects will be treated with the investigational device and followed per protocol. | Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)<br>* The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following | Symptomatic pulmonary embolism DVT anywhere in the deep venous system of the treatment limb Occlusive valve pocket thrombus (VPT) Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.) Device or procedure-related death | 30 day follow up | 
| Change in revised Venous Clinical Severity Score (rVCSS) from baseline | The rVCSS is an evaluative instrument that is used serially to assess changes in disease severity over time, as well as, in response to treatment for a patient. Scoring is from 0 to 30, and a decrease in the score indicates clinical improvement. | 1 year |