Critical Limb IschemiaNCT05313165
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A study testing LimFlow Stent Graft System in people with Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, run by LimFlow, Inc. at 30 sites in United States.
Trial summary
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
- What is being tested?
- LimFlow Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 30 sitesUnited States
- Study dates
- 22 Dec 2022to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 and ≤ 95 years of age
- Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
- Rutherford Classification 5, ischemic ulceration or
- Rutherford Classification 6, ischemic gangrene
- Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
- Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
Show all 16Show fewer
- Subject is willing and able to sign the informed consent form.
- Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.
- Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
- Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).
- Stable glycemic control, HbA1C < 10% (<269mg/dL)
- Subjects requiring dialysis may be included, provided they meet all the following requirements:
- On dialysis for > 6 months
- Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
- Serum albumin > 30 g/liter
- BMI > 20
Who cannot join
- Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
- Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
- Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
- Absence of adequate viable tissue in target foot.
- Life expectancy less than 12 months.
- Documented myocardial infarction or stroke within previous 90 days.
Show all 15Show fewer
- Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).
- Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
- Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).
- Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).
- Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.
- Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.
- Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
- Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 8 recruiting
- Completed
Presbyterian Healthcare
Albuquerque, New Mexico, 87113
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Erin McSweeney, 617-726-2264, emcsweeney@mgh.harvard.edu
Anahita Dua, MD
- Withdrawn
Boston Medical Center
Boston, Massachusetts, 02118
- Completed
Atrium Health
Charlotte, North Carolina, 28204
- Completed
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Amy McKnight, 216-983-4896, amy.mcknight@uhhospitals.org
Mehdi Shishehbor, MD
- Completed
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
Marti Roberson, 352-359-1561, mroberson@tcavi.com
Arthur Lee, MD
- Completed
University of Florida
Gainesville, Florida, 32608
- Completed
Penn State Health
Hershey, Pennsylvania, 17033
- Withdrawn
University of California, San Diego Health
La Jolla, California, 92093
- Recruiting
Northwell Health Long Island Jewish Medical Center
Lake Success, New York, 11042
Sally Kaplan, 516-233-3781, skaplan2@northwell.edu
Yana Etkin
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Michelle Keyes, 603-650-7966, Michelle.R.Keyes@hitchcock.org
Joceyln Beach, MD
- Withdrawn
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, 53211
- Withdrawn
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Celia Nunez, 615-322-4559, Celia.m.nunez@vumc.org
Daniel Clair
- Completed
Yale University
New Haven, Connecticut, 06519
- Completed
NYU Langone Health
New York, New York, 10016
- Completed
Mount Sinai
New York, New York, 10029
- Completed
Cornell University
New York, New York, 10065
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Sarah Havert, 757-388-2991, sshavert@sentara.com
David Dexter
- Completed
Stanford University School of Medicine
Palo Alto, California, 94304
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alice Chen, 267-521-7303, Alice.Chen1@Pennmedicine.upenn.edu
Elizabeth Genovese
- Completed
Vascular Institute of Atlantic Medical Imaging
Pomona, New Jersey, 08240
- Completed
UCSF
San Francisco, California, 94143
- Withdrawn
Washington University / Barnes Jewish
St Louis, Missouri, 63110
- Withdrawn
Tallahassee Research Institute
Tallahassee, Florida, 32308
- Completed
Holy Name Medical Center
Teaneck, New Jersey, 07666
- Completed
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
- Completed
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Read the detailed description
The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
- Being tested
- LimFlow Stent Graft System
- Keywords
- CLTI, PAD, CLI
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimFlow Stent Graft SystemDevice
Creation of an arteriovenous fistula in the desired limb location
| Study group | Role | What they receive |
|---|---|---|
| Treated with LimFlow | Experimental | Treatment with the LimFlow Stent Graft System Receives: Device: LimFlow Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation Free Survival
Freedom from major (above-ankle) amputation and death (all-cause mortality)
Measured: 6 Months
Secondary outcomes (30)
Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures
Measured: 30 Days
Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures
Measured: 6 Months
Primary Assisted Patency
Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred
Measured: 30 Days
Primary Assisted Patency
Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred
Measured: 6 Months
Secondary Patency
Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs
Measured: 30 Days
Secondary Patency
Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs
Measured: 6 Months
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Measured: 30 Days
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Measured: 3 Months
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Measured: 6 Months
Change in Rutherford Classification
A change of one class or greater
Measured: 30 Days
Change in Rutherford Classification
A change of one class or greater
Measured: 3 Months
Change in Rutherford Classification
A change of one class or greater
Measured: 6 Months
Technical Success
The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success
Measured: Intraprocedurally
Procedural Success
The combination of technical success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft
Measured: 30 Days
Target Wound Healing
Complete healing of the patient's target wound
Measured: 30 Days
Target Wound Healing
Complete healing of the patient's target wound
Measured: 3 Months
Target Wound Healing
Complete healing of the patient's target wound
Measured: 6 Months
Target Wound Healing
Complete healing of the patient's target wound
Measured: 12 Months
All Wound Healing
Complete healing of the patient's wounds
Measured: 30 Days
All Wound Healing
Complete healing of the patient's wounds
Measured: 3 Months
All Wound Healing
Complete healing of the patient's wounds
Measured: 6 Months
All Wound Healing
Complete healing of the patient's wounds
Measured: 12 Months
All Wound Area Reduction
Reduction in area of the patient's wounds
Measured: 30 Days
All Wound Area Reduction
Reduction in area of the patient's wounds
Measured: 3 Months
All Wound Area Reduction
Reduction in area of the patient's wounds
Measured: 6 Months
All Wound Area Reduction
Reduction in area of the patient's wounds
Measured: 12 Months
Freedom from Contrast-Induced Nephropathy
Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 μmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.
Measured: 72 hours
Procedure Time
The time of the first puncture (venous or arterial) to when the last catheter is removed
Measured: Intraprocedurally
Radiation Exposure
Patient radiation exposure (in milligray) during the procedure
Measured: Intraprocedurally
Contrast Volume
The total volume of contrast media (in milliliters) given during the procedure
Measured: Intraprocedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start22 Dec 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LimFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Clair, MD, Principal investigator, Vanderbilt UniversityMehdi Shishehbor, Principal investigator, University Hospital Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313165
- Sponsor's protocol ID
- LF-CA-PR-53
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial
- ClinicalTrials.gov ID
- NCT05313165
- Acronym / sponsor ID
- LF-CA-PR-53
- Keywords
- CLTI, PAD, CLI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LimFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Detailed description
The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated with LimFlow | Experimental | Device: LimFlow Stent Graft SystemTreatment with the LimFlow Stent Graft System |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subject must be ≥ 18 and ≤ 95 years of age
- Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
- Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
- Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
- Subject is willing and able to sign the informed consent form.
Key exclusion criteria (15 listed)
- Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
- Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
- Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.
- Absence of adequate viable tissue in target foot.
- Life expectancy less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LimFlow Stent Graft SystemCreation of an arteriovenous fistula in the desired limb location | Device | Treated with LimFlow |
Primary outcome
Amputation Free Survival
Time frame: 6 Months
Freedom from major (above-ankle) amputation and death (all-cause mortality)
30 secondary outcomes
Primary Patency
Time frame: 30 Days
Primary Patency
Time frame: 6 Months
Primary Assisted Patency
Time frame: 30 Days
Primary Assisted Patency
Time frame: 6 Months
Secondary Patency
Time frame: 30 Days
Secondary Patency
Time frame: 6 Months
Limb Salvage
Time frame: 30 Days
Limb Salvage
Time frame: 3 Months
Limb Salvage
Time frame: 6 Months
Change in Rutherford Classification
Time frame: 30 Days
Change in Rutherford Classification
Time frame: 3 Months
Change in Rutherford Classification
Time frame: 6 Months
Technical Success
Time frame: Intraprocedurally
Procedural Success
Time frame: 30 Days
Target Wound Healing
Time frame: 30 Days
Target Wound Healing
Time frame: 3 Months
Target Wound Healing
Time frame: 6 Months
Target Wound Healing
Time frame: 12 Months
All Wound Healing
Time frame: 30 Days
All Wound Healing
Time frame: 3 Months
All Wound Healing
Time frame: 6 Months
All Wound Healing
Time frame: 12 Months
All Wound Area Reduction
Time frame: 30 Days
All Wound Area Reduction
Time frame: 3 Months
All Wound Area Reduction
Time frame: 6 Months
All Wound Area Reduction
Time frame: 12 Months
Freedom from Contrast-Induced Nephropathy
Time frame: 72 hours
Procedure Time
Time frame: Intraprocedurally
Radiation Exposure
Time frame: Intraprocedurally
Contrast Volume
Time frame: Intraprocedurally
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. No plan to share
Related trials for Critical Limb Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Clair, MD principal investigator
Vanderbilt University
Mehdi Shishehbor principal investigator
University Hospital Cleveland
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LimFlow Stent Graft System in people with Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, run by LimFlow, Inc. at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Towery (888-478-7705, etowery@limflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation Free Survival (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.