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

NCT04225806 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-19

Study results available
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Summary

Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (CVI) of the lower extremity

Conditions

  • Chronic Venous Insufficiency (CVI)
  • Deep Vein Reflux

Interventions

DEVICE

BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)

The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.

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
2020-02-13
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04225806 on ClinicalTrials.gov