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

Not Applicable

Terminated

• Conditions: Deep Vein Reflux; Chronic Venous Insufficiency (CVI)
• Interventions: Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)

• Registration Number: NCT04225806
• Lead Sponsor: Intervene, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-02-13
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational	BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)	Subjects will be treated with the investigational device and followed per protocol.

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: The number of subjects experiencing a major adverse event (MAE), composed of the following	30 day follow up	* 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
Change in revised Venous Clinical Severity Score (rVCSS) from baseline	1 year	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.

Trial Locations

Locations (5)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Sentara Vascular Specialists; 🇺🇸 Norfolk, Virginia, United States

The Vascular Experts; 🇺🇸 Darien, Connecticut, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States