New balloon treatment could save legs from amputation
NCT ID NCT05055297
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special balloon coated with medicine (SELUTION SLR™ 014) to open blocked arteries below the knee in people with severe leg pain or wounds that threaten the limb. About 376 adults with chronic limb-threatening ischemia will be randomly assigned to get either the drug-coated balloon or a standard uncoated balloon. The goal is to see if the coated balloon better prevents amputation, repeat procedures, and artery re-blockage.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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Contacts and locations
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Study contacts
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Advocate Lutheran General Hospital
RECRUITINGPark Ridge, Illinois, 60068, United States
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Alexianer Klinikum Hochsauerland
RECRUITINGArnsberg, 59759, Germany
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Ambroise Paré Hospital
RECRUITINGBoulogne-Billancourt, 92100, France
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Arkansas Heart Hospital
TERMINATEDLittle Rock, Arkansas, 72211, United States
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Auckland City Hospital
RECRUITINGAuckland, 1023, New Zealand
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Baylor College of Medicine
RECRUITINGHouston, Texas, 77030, United States
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Beth Israel Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Cardiovascular Consultants of South Georgia
TERMINATEDThomasville, Georgia, 31792, United States
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Cardiovascular Institute of the South
RECRUITINGGray, Louisiana, 70359, United States
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Chandler Regional Medical Center
RECRUITINGChandler, Arizona, 85297, United States
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Christus Health
RECRUITINGTyler, Texas, 75702, United States
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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ClinRé
TERMINATEDThornton, Colorado, 80023, United States
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El Paso Cardiology
RECRUITINGEl Paso, Texas, 79912, United States
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Guardian Research Organization, LLC
RECRUITINGWinter Park, Florida, 32792, United States
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Hightower Clinical Research
RECRUITINGOklahoma City, Oklahoma, 73134, United States
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Hôpital St. Joseph
RECRUITINGParis, 75014, France
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Inselspital Bern
TERMINATEDBern, Switzerland
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Krankenhaus Buchholz
RECRUITINGBuchholz, 21244, Germany
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LKH-Universitätsklinikum Graz
RECRUITINGGraz, A-8036, Austria
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Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
RECRUITINGTorrance, California, 90502, United States
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MedStar Health Research Institute
RECRUITINGHyattsville, Maryland, 20782, United States
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Miriam Hospital
RECRUITINGProvidence, Rhode Island, 02906, United States
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NC Heart and Vascular Research, LLC
RECRUITINGRaleigh, North Carolina, 27607, United States
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Ospedale Pederzoli
RECRUITINGPeschiera del Garda, Verona, 37019, Italy
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Ospedale Policlinico San Martino
TERMINATEDGenova, 16132, Italy
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Palm Vascular Centers
RECRUITINGMiami, Florida, 33141, United States
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Queen Mary Hospital
RECRUITINGHong Kong, Pok Fu Lam, Hong Kong
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Rush University Medical Center
RECRUITINGChicago, Illinois, 60612, United States
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Sana Kliniken Oberfranken Coburg
RECRUITINGCoburg, 96450, Germany
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Singapore General Hospital
RECRUITINGSingapore, 169856, Singapore
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Sorin Medical Group
RECRUITINGNew York, New York, 10005, United States
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St. Antonius Hospital
RECRUITINGNieuwegein, 3435 CM, Netherlands
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St. Bernards Medical Center
RECRUITINGJonesboro, Arkansas, 72401, United States
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St. Helena Hospital
TERMINATEDSt. Helena, California, 94574, United States
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Tennessee Center for Clinical Trials
SUSPENDEDTullahoma, Tennessee, 37388, United States
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Texas Cardiac and Vascular Institute San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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The Cardiac and Vascular Institute Research Foundation
RECRUITINGGainesville, Florida, 32605, United States
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The Chinese University of Hong Kong
RECRUITINGHong Kong, Shatin, Hong Kong
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UGC - Maria Cecilia Hospital
RECRUITINGCotignola, 48033, Italy
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Universitatsklinikum Tubingen
RECRUITINGTübingen, Germany
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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University of Essen
RECRUITINGEssen, 45147, Germany
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University of Massachusetts Medical Center
RECRUITINGWorcester, Massachusetts, 01655, United States
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Universitäts-Herzzentrum Freiburg - Bad Krozingen
RECRUITINGBad Krozingen, 79189, Germany
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Vascular Care Group
RECRUITINGDarien, Connecticut, 06820, United States
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Yale University
RECRUITINGNew Haven, Connecticut, 06519, United States
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