Actively Recruiting
Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
Led by LimFlow, Inc. · Updated on 2026-04-16
100
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to provide additional information on the LimFlow System for treating late-stage chronic limb-threatening ischemia in patients who cannot have standard endovascular or surgical limb salvage procedures. The study focuses on using a minimally invasive approach to create an arteriovenous connection in the below-the-knee blood vessels to arterialize the pedal veins and improve blood flow in the affected limb. Participants will be treated with the LimFlow Stent Graft System, which creates an arteriovenous fistula in the target limb through a percutaneous, endovascular procedure. This single-arm, multi-center study involves one treatment group receiving this device to assess its use and effects in this patient population. During the study, participants will undergo assessments including wound healing evaluations, limb salvage status, and patency of the treated vessels at multiple time points up to 12 months. Researchers will monitor amputation-free survival at 6 months as the primary outcome and assess other clinical and procedural outcomes such as technical success, wound size reduction, and safety measures. Participants will be followed for ongoing evaluation of treatment impact and safety.
CONDITIONS
Brief 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 18 to 95 years
- Clinical diagnosis of chronic limb-threatening ischemia with severely reduced blood flow in the affected limb
- Rutherford Classification 5 (ischemic ulceration) or 6 (ischemic gangrene)
- No feasible conventional surgical or endovascular limb salvage options due to absence of usable pedal artery target or vein conduit
- Target inflow artery diameter suitable for LimFlow stent graft
- Willing and able to sign informed consent
- Enrolled in an adequate wound care network with support for medication adherence and follow-up
- Negative pregnancy test within 7 days prior to enrollment for women of childbearing potential
- Stable primary wound (not rapidly worsening or showing healing signs)
- Stable glycemic control with HbA1C below 10% (below 269 mg/dL)
- Dialysis patients eligible if on dialysis >6 months with autologous AV fistula or peritoneal access, serum albumin >30 g/L, and BMI >20
You will not qualify if you...
- Liver failure, thrombophlebitis in target limb, or untreatable clotting disorder within past 90 days
- Active immunodeficiency or on immunosuppressants for it
- Prior peripheral arterial bypass above or below knee affecting stent graft inflow
- Lack of viable tissue in the target foot
- Life expectancy under 12 months
- Heart attack or stroke within past 90 days
- Active infection that may prevent device insertion or require major amputation
- Allergies or contraindications to aspirin, P2Y12 inhibitors, heparin, metals in device, or contrast agent
- Use of anticoagulants that interfere with study participation
- Vascular diseases or conditions in lower limb that may hinder procedure or wound healing
- Severe kidney disease with serum creatinine over 2.5 mg/dL (unless on dialysis)
- Severe heart failure (NYHA Class IV) compromising procedure safety
- Significant medical, psychological, or social conditions interfering with participation
- Current participation in another investigational drug or device trial impacting this study
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive the LimFlow Stent Graft System to create an arteriovenous fistula in the affected limb using a minimally invasive approach.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for wound healing, limb salvage, and device patency after the procedure.
Multiple follow-up visits over 12 months
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
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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