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

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

Study Overview

• Status: Terminated
• Conditions: Chronic Venous Insufficiency (CVI); Deep Vein Reflux
• Intervention / Treatment: Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Darien, Connecticut, United States, 06820
      • The Vascular Experts
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 conflict with this study or compromise study results
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational; Subjects will be treated with the investigational device and followed per protocol.	Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System); 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.

What is the study measuring?

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 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

Collaborators and Investigators

• Sponsor: Intervene, Inc.
• Investigators: Study Director: Jeff Elkins, Intervene, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency
• Other Study ID Numbers: CLN004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes