RecruitingNot ApplicableNCT05055297

SELUTION4BTK Trial

SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)

Sponsor

M.A. Med Alliance S.A.

Enrollment

376 participants

Start Date

May 19, 2022

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

Summary

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Plain (Uncoated) Balloon Angioplasty (PTA) and a medical device called SELUTION SLR™ DEB 014 for people with chronic limb-threatening ischemia nos of native arteries of extremities and peripheral arterial disease. The study is currently recruiting participants at 48 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESELUTION SLR™ DEB 014

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

DEVICEPlain (Uncoated) Balloon Angioplasty (PTA)

a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

Locations(48)

Chandler Regional Medical Center

Chandler, Arizona, United States

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

St. Helena Hospital

St. Helena, California, United States

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, United States

ClinRé

Thornton, Colorado, United States

Vascular Care Group

Darien, Connecticut, United States

Yale University

New Haven, Connecticut, United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States

Palm Vascular Centers

Miami, Florida, United States

Guardian Research Organization, LLC

Winter Park, Florida, United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Cardiovascular Institute of the South

Gray, Louisiana, United States

MedStar Health Research Institute

Hyattsville, Maryland, United States

Beth Israel Medical Center

Boston, Massachusetts, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Sorin Medical Group

New York, New York, United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hightower Clinical Research

Oklahoma City, Oklahoma, United States

Miriam Hospital

Providence, Rhode Island, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States

El Paso Cardiology

El Paso, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, United States

Christus Health

Tyler, Texas, United States

LKH-Universitätsklinikum Graz

Graz, Austria

Ambroise Paré Hospital

Boulogne-Billancourt, France

Hôpital St. Joseph

Paris, France

Alexianer Klinikum Hochsauerland

Arnsberg, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Krankenhaus Buchholz

Buchholz, Germany

Sana Kliniken Oberfranken Coburg

Coburg, Germany

University of Essen

Essen, Germany

Universitatsklinikum Tubingen

Tübingen, Germany

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Ospedale Pederzoli

Peschiera del Garda, Verona, Italy

UGC - Maria Cecilia Hospital

Cotignola, Italy

Ospedale Policlinico San Martino

Genova, Italy

St. Antonius Hospital

Nieuwegein, Netherlands

Auckland City Hospital

Auckland, New Zealand

Singapore General Hospital

Singapore, Singapore

Inselspital Bern

Bern, Switzerland

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NCT05055297

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