Actively Recruiting
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Led by LimFlow, Inc. · Updated on 2026-04-16
100
Participants Needed
30
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
CONDITIONS
Official Title
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 95 years
- Clinical diagnosis of chronic limb-threatening ischemia with severely reduced arterial blood flow in the affected limb
- Presence of ischemic ulceration or gangrene classified as Rutherford 5 or 6
- No feasible conventional surgical or endovascular limb salvage options due to lack of usable pedal artery target or viable vein for bypass
- Target inflow artery falls within vessel size suitable for LimFlow stent graft
- Willing and able to sign informed consent
- Enrolled in a wound care network with adequate support for medication and follow-up
- Negative pregnancy test for women of childbearing potential within 7 days before enrollment
- Stable primary wound without rapid deterioration
- Stable blood sugar control with HbA1C less than 10%
- Dialysis patients may be included if on dialysis for more than 6 months, using autologous fistula or peritoneal access, serum albumin above 30 g/liter, and BMI over 20
You will not qualify if you...
- Hepatic insufficiency, thrombophlebitis in target limb, or untreatable coagulation disorder within past 90 days
- Active immunodeficiency or current immunosuppressant therapy for immunodeficiency
- Prior peripheral arterial bypass above or below knee that limits proximal inflow
- Lack of viable tissue in target foot
- Life expectancy under 12 months
- Myocardial infarction or stroke within previous 90 days
- Active infection that may prevent prosthesis insertion or require major amputation
- Allergies or contraindications to aspirin, P2Y12 inhibitors, heparin, stainless steel, nitinol, or contrast agents that cannot be treated
- Current use of anticoagulants that interfere with study participation
- Lower extremity vascular diseases like vasculitis, Buerger's disease, significant edema, deep vein thrombosis, hyperpigmentation, or ulcers above ankle
- Severe kidney disease with serum creatinine over 2.5 mg/dl if not on dialysis
- Severe heart failure (NYHA Class IV) that may risk safety during procedure
- Significant medical, psychological, or social conditions that interfere with participation
- Participation in another investigational drug or device study affecting study endpoints
- Unwillingness or inability to comply with protocol or follow-up requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
University of California, San Diego Health
La Jolla, California, United States, 92093
Withdrawn
2
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Completed
3
UCSF
San Francisco, California, United States, 94143
Completed
4
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Completed
5
Yale University
New Haven, Connecticut, United States, 06519
Completed
6
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Actively Recruiting
7
University of Florida
Gainesville, Florida, United States, 32608
Completed
8
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Withdrawn
9
Rush University Medical Center
Chicago, Illinois, United States, 60612
Completed
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
Boston Medical Center
Boston, Massachusetts, United States, 02118
Withdrawn
12
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Completed
13
Washington University / Barnes Jewish
St Louis, Missouri, United States, 63110
Withdrawn
14
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Actively Recruiting
15
Vascular Institute of Atlantic Medical Imaging
Pomona, New Jersey, United States, 08240
Completed
16
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Completed
17
Presbyterian Healthcare
Albuquerque, New Mexico, United States, 87113
Completed
18
Northwell Health Long Island Jewish Medical Center
Lake Success, New York, United States, 11042
Actively Recruiting
19
NYU Langone Health
New York, New York, United States, 10016
Completed
20
Mount Sinai
New York, New York, United States, 10029
Completed
21
Cornell University
New York, New York, United States, 10065
Completed
22
Atrium Health
Charlotte, North Carolina, United States, 28204
Completed
23
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Penn State Health
Hershey, Pennsylvania, United States, 17033
Completed
25
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
26
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
27
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Completed
28
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Actively Recruiting
29
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States, 53211
Withdrawn
30
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
E
Erin Towery
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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