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

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ClinicalTrials.gov Identifier: NCT03216005
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Intervene, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Device: BlueLeaf System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, non-randomized, multicenter pre-market feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

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.




Primary Outcome Measures :
  1. 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 ]
  2. Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study. [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216005


Contacts
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Contact: Tracy Roberts 303-396-4603 tracy@intervene-med.com

Locations
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Australia, New South Wales
Royal Prince Alfred Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Lisa Turner       Lisa.Turner@health.nsw.gov.au   
Principal Investigator: David Robinson, FRACS         
Prince of Wales Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Kimberley Bassett       rvarcoe@people.net.au   
Principal Investigator: A/Prof Varcoe         
Sub-Investigator: Dr Thomas         
Canada, British Columbia
Vancouver Coastal Health Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Michelle Storms       michelle.storms@vch.ca   
Principal Investigator: Dr. Gagnon         
Sub-Investigator: Dr. Machan         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand
Contact: Helen Knight       HKnight@adhb.govt.nz   
Principal Investigator: Andrew Hill, FRACS         
Sub-Investigator: Andrew Holden, FRANZCR         
Clinical Trials New Zealand Ltd Recruiting
Hamilton, New Zealand
Contact: Eileen Bisley       eileen@clinicaltrialsnz.com   
Principal Investigator: Thodur Vasudevan, MD         
Sponsors and Collaborators
Intervene, Inc.
Investigators
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Study Director: Fletcher Wilson Intervene, Inc.
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Responsible Party: Intervene, Inc.
ClinicalTrials.gov Identifier: NCT03216005    
Other Study ID Numbers: CLN 003
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases