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

NCT05047302 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-08-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Venous Insufficiency

Interventions

DEVICE

BlueLeaf Procedure

The device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant.

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
2022-10-01
Primary Completion
2025-11-01
Completion
2026-11-01

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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 NCT05047302 on ClinicalTrials.gov