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Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

NCT03216005 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-23

Study results available
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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

Interventions

DEVICE

BlueLeaf System

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

Sponsors & Collaborators

  • Intervene, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeff Elkins · Intervene, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Device
Yes

Countries

  • Australia
  • Canada
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216005 on ClinicalTrials.gov