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PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

NCT03124875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-05-21

Study results available
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Summary

This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Conditions

  • Critical Limb Ischemia
  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

LimFlow System

Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.

Sponsors & Collaborators

  • LimFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Jihad Mustapha, MD · Metro Health, University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2019-08-08
Completion
2021-01-05
FDA Device
Yes

Countries

  • United States

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 NCT03124875 on ClinicalTrials.gov