Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Trial

NARecruitingINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

December 31, 2023

Primary Completion Date

August 30, 2025

Study Completion Date

December 30, 2025

Conditions
Treatment in Calcified Coronary Disease
Interventions
DEVICE

Intravascular Lithotripsy

Intravascular lithotripsy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

DEVICE

Cutting Balloon

Cutting Balloon therapy will be performed with or without rotational atherectomy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

Trial Locations (22)

10032

RECRUITING

Columbia Cardiology, New York

NOT_YET_RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital, New York

12211

RECRUITING

Capital Cardiology, Albany

13400

RECRUITING

Honor Health, Scottsdale

15213

RECRUITING

UPMC, Pittsburgh

17403

RECRUITING

Wellspan York Hospital, York

22903

RECRUITING

UVA Heart and Vascular Center, Charlottesville

35233

RECRUITING

UAB Structural Heart and Valve Clinic, Birmingham

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

45219

RECRUITING

Christ Hospital, Cincinnati

48202

RECRUITING

Henry Ford Health, Detroit

66207

RECRUITING

Saint Luke's, Overland Park

75024

RECRUITING

Baylor Scott and White Health, Plano

75226

RECRUITING

Baylor Heart and Vascular Hospital, Dallas

77030

RECRUITING

Houston Methodist, Houston

85012

RECRUITING

Banner Health, Phoenix

94117

RECRUITING

UCSF Cardiology, San Francisco

98195

RECRUITING

University of Washington, Seattle

06510

RECRUITING

Yale School of Medicine, New Haven

04102

RECRUITING

Maine Medical Center, Portland

02115

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medcial Center, Boston

All Listed Sponsors
collaborator

Robert W. Yeh, MD

UNKNOWN

collaborator

Ajay Kirtane, MD

UNKNOWN

collaborator

C. Michael Gibson, MS, MD

UNKNOWN

collaborator

Kathleen Kearney, MD

UNKNOWN

collaborator

Akiko Maehara, MD

UNKNOWN

collaborator

Suzanne Baron, MD

UNKNOWN

lead

Baim Institute for Clinical Research

OTHER