SELUTION SLR™ 014 In-stent Restenosis

NAActive, not recruitingINTERVENTIONAL
Enrollment

418

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

August 15, 2025

Study Completion Date

August 31, 2029

Conditions
Coronary Restenosis
Interventions
DEVICE

SELUTION SLR™ DEB

The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus).

DEVICE

Control

POBA or FDA-approved -limus DES

Trial Locations (48)

1105

Amsterdam UMC, Academic Medical Centre, Amsterdam

3584

UMC Utrecht, Utrecht

9718

UMCG, Groningen

10029

Mount Sinai Hospital, New York

11576

St. Francis Hospital & Heart Center, Roslyn

17033

Pennsylvania State University Milton S. Hershey Medical Center, Hershey

17104

UPMC Pinnacle Health, Harrisburg

20010

MedStar Heart Institute, Washington D.C.

20089

Instituto Clinico Humanitas Milan, Milan

21000

Clinique Valmy, Dijon

21201

University of Maryland, Baltimore

23225

HCA Chippenham/VA Cardiovascular Specialists, Richmond

27401

Moses H. Cone Memorial Hospital, Greensboro

27607

NC Heart and Vascular Research, LLC, Raleigh

30033

Atlanta VA Medical Center, Atlanta

30309

Piedmont Heart Institute, Atlanta

31400

CHU Toulouse Rangueil, Toulouse

32209

University of Florida Health, Jacksonville

33176

Baptist Cardiac & Vascular Institute, Miami

35128

Center Azienda Ospedaliero Universitaria de Padova, Padua

37203

HCA Centennial, Nashville

45219

The Christ Hospital, Cincinnati

46260

Ascension St Vincents Heart Center, Indianapolis

48033

Maria Cecilia Hospital, Cotignola

48073

Beaumont Hospital, Royal Oak

48075

Ascension St John Hospital, Southfield

49048

Ascension Borgess Heart Institute, Kalamazoo

55407

Minneapolis Heart Institute, Minneapolis

67226

Ascension Via Christi, Wichita

73112

Integris, Oklahoma City

75204

Baylor Scott & White, Dallas

76000

Clinique Saint Hilaire, Rouen

76508

Baylor Scott & White, Temple

79430

Texas Tech University Health Sciences Center, Lubbock

80023

ClinRe 001-001, Thornton

90048

Cedars-Sinai Medical Center, Los Angeles

90502

Harbor-UCLA Medical Center, Torrance

91300

Hôpital privé Jacques Cartier, Massy

92354

Loma Linda University, Loma Linda

02215

Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston

03102

Manchester Catholic Medical Center, Manchester

07960

Morristown Medical Center, Morristown

08901

Rutgers, Robert Wood Johnson Medical School, New Brunswick

02903

Lifespan Cardiovascular Institute, Providence

Unknown

HartCentrum Hasslet, Jessa Ziekenhuis, Hasselt

04012-180

Instituto Dante Pazzanese de Cardiologia, São Paulo

05403-900

Instituto do Coração - São Paulo University, São Paulo

L8N 3Z5

Hamilton Health Sciences, Hamilton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Iqvia Pty Ltd

INDUSTRY

collaborator

Cordis Corporation

INDUSTRY

lead

M.A. Med Alliance S.A.

INDUSTRY