ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

July 1, 2024

Study Completion Date

September 1, 2024

Conditions
Calcified Coronary Artery Disease
Interventions
DEVICE

Super High Pressure Balloon (OPN NC)

"Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty.~Optical coherence tomography (OCT) imaging will be performed after lesion preparation with OPN balloon. Optional additional pre-dilatation with OPN/standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with OPN balloon or standard NC balloon is permitted at the operator´s discretion."

DEVICE

Intravascular lithotripsy (IVL)

"Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty.~Optical coherence tomography (OCT) imaging will be performed after lesion preparation with IVL balloon. Optional additional pre-dilatation with standard NC balloon is permitted at the operator´s discretion. Following lesion preparation, stenting will be performed in the same setting using a latest-generation everolimus-eluting stent (XIENCE; Abbott Vascular, Chicago, IL, USA). Optional post-dilatation with standard NC balloon is permitted at the operator´s discretion."

Trial Locations (4)

77933

RECRUITING

MEDICLIN Herzzentrum Lahr, Lahr

Unknown

RECRUITING

Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum, Bad Oeynhausen

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt am Main

RECRUITING

Deutsches Herzzentrum Muenchen, München

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott Medical Devices

INDUSTRY

collaborator

SIS Medical AG

INDUSTRY

lead

Deutsches Herzzentrum Muenchen

OTHER