SELUTION4SFA Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

June 24, 2026

Study Completion Date

December 1, 2030

Conditions
Peripheral Arterial DiseaseSuperficial Femoral Artery Stenosis
Interventions
DEVICE

SELUTION SLR™ 018 DEB

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

DEVICE

Plain (Uncoated) Balloon Angioplasty (PTA)

a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

Trial Locations (42)

10468

James J. Peters VA Medical Center, The Bronx

11766

Mount Sinai, New York

20782

MedStar Health Research Institute, Hyattsville

21244

Krankenhaus Buchholz, Buchholz

27607

NC Heart and Vascular Research, LLC, Raleigh

30322

Emory University Hospital, Atlanta

31792

Cardiovascular Consultants of South Georgia, Thomasville

32218

First Coast Cardiovascular Institute, Jacksonville

32605

The Cardiac and Vascular Institute Research Foundation, Gainesville

32792

Guardian Research Organization, LLC, Winter Park

33021

Memorial Healthcare System, Hollywood

33140

Palm Vascular Centers, Miami Beach

34205

Manatee Memorial Hospital, Bradenton

37388

Tennessee Center for Clinical Trials, Tullahoma

43214

OhioHealth Riverside Hospital, Columbus

44195

Cleveland Clinic, Cleveland

59759

Alexianer Klinikum Hochsauerland, Arnsberg

60068

Advocate Lutheran General Hospital, Park Ridge

60464

Heart Care Centers Research Foundation, Palos Park

60612

Rush University Medical Center, Chicago

63128

Mercy Hospital, St Louis

70359

Cardiovascular Institute of the South, Gray

72076

University Clinic Tübingen, Tübingen

72211

Arkansas Heart Hospital, Little Rock

72401

St. Bernards Medical Center, Jonesboro

75093

Heart Hospital Baylor Plano, Plano

77030

Baylor College of Medicine, Houston

78229

Texas Cardiac and Vascular Institute San Antonio, San Antonio

79189

Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen

79902

El Paso Cardiology, El Paso

80023

ClinRé, Thornton

83022

RoMed Klinikum Rosenheim, Rosenheim

94538

Mission Cardiovascular Research Institute, Fremont

94558

St. Helena Hospital, St. Helena

06820

Vascular Care Group, Darien

06519

Yale University, New Haven

07666

Holy Name Medical Center, Teaneck

02906

Miriam Hospital, Providence

A-8036

Universitätsklinikum Graz, Graz

04103

Universitätsklinikum Leipzig, Leipzig

Unknown

Queen Mary Hospital, Hong Kong

The Chinese University of Hong Kong, Shatin

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

NAMSA

OTHER

collaborator

Cordis Corporation

INDUSTRY

lead

M.A. Med Alliance S.A.

INDUSTRY