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PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

NCT05313165 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-16

No results posted yet for this study

Summary

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Conditions

  • Critical Limb Ischemia
  • Chronic Limb-Threatening Ischemia
  • Peripheral Arterial Disease

Interventions

DEVICE

LimFlow Stent Graft System

Creation of an arteriovenous fistula in the desired limb location

Sponsors & Collaborators

  • LimFlow, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Clair, MD · Vanderbilt University

  • Mehdi Shishehbor · University Hospital Cleveland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2027-05-01
Completion
2027-05-01
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 NCT05313165 on ClinicalTrials.gov