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

ClinicalTrials.gov ID: NCT03970538

Public ClinicalTrials.gov record NCT03970538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 8, 2026, 5:40 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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").

Study identification

NCT ID
NCT03970538
Recruitment status
Not listed
Study type
Interventional
Phase
Not applicable
Lead sponsor
LimFlow, Inc.
Industry
Enrollment
105 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 95 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 6, 2019 (Actual)
Primary completion
Sep 9, 2022 (Actual)
Completion
Feb 28, 2025 (Estimated)
Last update posted
Feb 28, 2024

2019 – 2025

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
University of California San Francisco San Francisco California 94143 —
Harbor-UCLA Medical Center Torrance California 90502 —
Yale University New Haven Connecticut 06519 —
The Cardiac and Vascular Institute Gainesville Florida 32605 —
University of Florida Gainesville Florida 32608 —
Unitypoint Health Des Moines Iowa 50309 —
Ochsner Health System Kenner Louisiana 70065 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston Medical Center Boston Massachusetts 02118 —
Saint Luke's Hospital Lee's Summit Missouri 64086 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03766 —
New Mexico Heart Institute Albuquerque New Mexico 87102 —
Atrium Health Charlotte North Carolina 28203 —
Coastal Carolina Surgical Associates Wilmington North Carolina 28401 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Prisma Health -- Midlands Columbia South Carolina 29203 —
Prisma Health -- Upstate Greenville South Carolina 29615 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Seton Heart Austin Texas 78723 —
Baylor College of Medicine Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03970538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 28, 2024 · Synced Nov 8, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03970538 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →