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

NCT03970538 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2024-02-28

Study results available
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Summary

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option").

Conditions

  • Critical Limb Ischemia
  • Critical Lower Limb Ischemia
  • Peripheral Artery Disease
  • Peripheral Arterial Disease
  • Chronic Limb-Threatening Ischemia
  • Arterial Occlusive Diseases
  • Arterial Occlusion
  • Arterial Disease
  • Peripheral Artery Occlusion
  • Peripheral Vascular Disease
  • Peripheral Ischemia
  • Vascular Diseases

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

  • 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
2019-12-06
Primary Completion
2022-09-09
Completion
2025-02-28
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

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 NCT03970538 on ClinicalTrials.gov