New device aims to prevent amputation in patients with no other options

NCT ID NCT05313165

Disease control Sponsor: LimFlow, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called the LimFlow Stent Graft System for people with late-stage chronic limb-threatening ischemia, a severe form of peripheral artery disease where blood flow to the leg is critically low. The device creates a new connection between a vein and artery to reroute blood around blockages. The main goal is to see if this can help patients avoid major amputation and survive longer. The trial plans to enroll 100 participants across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: LimFlow Stent Graft System (a device that creates a new channel between a vein and artery in the leg)
What this could lead to: If successful, this could offer a new way to save the legs of people with severe blockages who have no other options, avoiding amputation.
What could go wrong: This is a single-arm study with no comparison group, so results may be less definitive. The procedure is new and carries risks like infection, bleeding, or device failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must be ≥ 18 and ≤ 95 years of age 2. 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 1. Rutherford Classification 5, ischemic ulceration or 2. Rutherford Classification 6, ischemic gangrene 3. 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. 4. 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. 5. Subject is willing and able to sign the informed consent form. 6. 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. 7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test. 8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing). 9. Stable glycemic control, HbA1C \< 10% (\<269mg/dL) 10. 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 Exclusion Criteria: 1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days. 2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder. 3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft. 4. Absence of adequate viable tissue in target foot. 5. Life expectancy less than 12 months. 6. Documented myocardial infarction or stroke within previous 90 days. 7. 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). 8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated. 9. 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). 10. 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). 11. Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in subjects not undergoing dialysis. 12. 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. 13. 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. 14. 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. 15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic limb-threatening ischemia Critical limb ischemia Peripheral arterial disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

8 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ascension Columbia St. Mary's Hospital
WITHDRAWN

Milwaukee, Wisconsin, 53211, United States
Atrium Health
COMPLETED

Charlotte, North Carolina, 28204, United States
Boston Medical Center
WITHDRAWN

Boston, Massachusetts, 02118, United States
Cornell University
COMPLETED

New York, New York, 10065, United States
Dartmouth-Hitchcock Medical Center
RECRUITING

Lebanon, New Hampshire, 03766, United States
Holy Name Medical Center
COMPLETED

Teaneck, New Jersey, 07666, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
COMPLETED

Torrance, California, 90502, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Mount Sinai
COMPLETED

New York, New York, 10029, United States
NYU Langone Health
COMPLETED

New York, New York, 10016, United States
Northwell Health Long Island Jewish Medical Center
RECRUITING

Lake Success, New York, 11042, United States
Penn State Health
COMPLETED

Hershey, Pennsylvania, 17033, United States
Presbyterian Healthcare
COMPLETED

Albuquerque, New Mexico, 87113, United States
Rush University Medical Center
COMPLETED

Chicago, Illinois, 60612, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507, United States
Stanford University School of Medicine
COMPLETED

Palo Alto, California, 94304, United States
Tallahassee Research Institute
WITHDRAWN

Tallahassee, Florida, 32308, United States
The Cardiac and Vascular Institute
RECRUITING

Gainesville, Florida, 32605, United States
The Medical College of Wisconsin
WITHDRAWN

Milwaukee, Wisconsin, 53226, United States
UCSF
COMPLETED

San Francisco, California, 94143, United States
UMass Chan Medical School
COMPLETED

Worcester, Massachusetts, 01655, United States
UT Southwestern Medical Center
COMPLETED

Dallas, Texas, 75390, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University of California, San Diego Health
WITHDRAWN

La Jolla, California, 92093, United States
University of Florida
COMPLETED

Gainesville, Florida, 32608, United States
University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37212, United States
Vascular Institute of Atlantic Medical Imaging
COMPLETED

Pomona, New Jersey, 08240, United States
Washington University / Barnes Jewish
WITHDRAWN

St Louis, Missouri, 63110, United States
Yale University
COMPLETED

New Haven, Connecticut, 06519, United States

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