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

NCT04225806 | Terminated Results DMC FDA Device

• 1 other identifier: CLN004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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 chronic venous insufficiency (CVI) of the lower extremity

Conditions

Chronic Venous Insufficiency (CVI); Deep Vein Reflux

Outcome Measures

Primary Outcomes (2)

• 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 post-procedure

• Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline

  Assessment of changes in the rVCSS; the score is a composite based on a rating score of none (0), mild (1), moderate (2) and severe (3) for symptoms and clinical signs, the number of active ulcers (0, 1, 2, \>/=3), duration of ulcers (\<3 months, \>3 months but \<1 year, not healed for \>1 year), active ulcer size (diameter \<2cm, diameter 2-6cm, and diameter \>6cm), and use of compression therapy (not used (0), intermittent use of stockings (1), wears stockings most days (2), and full compliance (3)). A higher VCSS would indicate a worse outcome.

  Baseline, 30-days, 12-weeks, 210-days and 365-days post-procedure

Study Arms (1)

Investigational

EXPERIMENTAL

Subjects will be treated with the investigational device and followed per protocol.

Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)

Interventions

BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) DEVICE

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.

Investigational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• mm 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intervene, Inc.: lead

Study Sites (5)

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Limitations and Caveats

Trial was terminated early by Sponsor, and therefore, analysis of data is limited to available information.

Results Point of Contact

• Title: Clinical Affairs
• Organization: InterVene, Inc

ClinSupport@intervene-med.com

6509957137

Study Officials

• Jeff Elkins

  Intervene, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: February 13, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)