Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

NCT03216005 | Terminated Results FDA Device

• 1 other identifier: CLN003
• Study Type: interventional
• Target: 14
• Locations: 3 countries
• Sites: 5

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).

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment

  Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up

  Baseline, 7-day, 30-day

• Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)

  Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit

  30-day post-procedure

Secondary Outcomes (2)

• Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment

  90-day, 210-day

• Change in Reflux Time (RT) in the Primary Treated Vein Segment

  90-day, 210-day

Other Outcomes (7)

• Procedure Technical Success

  Procedure

• Average Revised Venous Clinical Severity Score (rVCSS)

  Baseline, 30-day, 90-day

• Change in Revised Venous Clinical Severity Score (rVCSS)

  30-day, 90-day

Study Arms (1)

BlueLeaf System

EXPERIMENTAL

The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Device: BlueLeaf System

Interventions

BlueLeaf System DEVICE

The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

BlueLeaf System

Eligibility Criteria

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

You may qualify if:

• 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.

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;
• 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;

Sponsors & Collaborators

• Intervene, Inc.: lead

Study Sites (5)

Royal Prince Alfred

Camperdown, New South Wales, 2050, Australia

Location

Prince of Wales

Randwick, New South Wales, 2031, Australia

Location

Vancouver Coastal Health Research Institute

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Auckland City Hospital

Auckland, New Zealand

Location

Clinical Trials New Zealand Ltd

Hamilton, New Zealand

Location

Limitations and Caveats

The trial was terminated early leading to a limited number of subjects analyzed. Specifically, there was limited data available for reporting purposes.

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

Model Details: prospective, non-randomized, multicenter pre-market feasibility study

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 12, 2017
• Study Start: November 2, 2017
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 23, 2026
• Results First Posted: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CA (1); NZ (2)