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

NCT ID NCT05313165

Recruiting now 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.

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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

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WITHDRAWN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WITHDRAWN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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