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

September 8, 2021 updated by: Intervene, Inc.
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Prince of Wales
        • Contact:
        • Principal Investigator:
          • A/Prof Varcoe
        • Sub-Investigator:
          • Dr Thomas
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver Coastal Health Research Institute
        • Contact:
        • Principal Investigator:
          • Dr. Gagnon
        • Sub-Investigator:
          • Dr. Machan
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Auckland City Hospital
        • Contact:
        • Principal Investigator:
          • Andrew Hill, FRACS
        • Sub-Investigator:
          • Andrew Holden, FRANZCR
      • Hamilton, New Zealand
        • Recruiting
        • Clinical Trials New Zealand Ltd
        • Contact:
        • Principal Investigator:
          • Thodur Vasudevan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
  • Failed compression therapy of at least 6 months' duration;
  • Deep system venous reflux characterized by >1 second reflux time;
  • Presence of at least one target site within the target vessel.

Exclusion Criteria:

  • Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
  • Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
  • Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
  • Acute deep venous thrombosis (DVT) within 3 months of consent;
  • History of stroke within the last 6 months;
  • Flow-limiting venous outflow obstruction central to the intended target sites;
  • Insufficient inflow through the treatment vein upon manual augmentation;
  • Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
  • Chronic renal insufficiency with creatinine level of ≥2mg/dL;
  • Hemoglobin level <9.0 mg/dL;
  • Platelet count <50,000 or >1,000,000 per mm3;
  • Total white blood cell count <3,000/mm3;
  • Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
  • Non-ambulatory patients;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Device: BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
Time Frame: 30 days
30 days
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intervene, Inc.

Investigators

  • Study Director: Fletcher Wilson, Intervene, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 8, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 003

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

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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