80
Participants
Start Date
December 1, 2022
Primary Completion Date
July 1, 2024
Study Completion Date
September 1, 2024
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."
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."
RECRUITING
MEDICLIN Herzzentrum Lahr, Lahr
RECRUITING
Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum, Bad Oeynhausen
RECRUITING
Universitätsklinikum Frankfurt, Frankfurt am Main
RECRUITING
Deutsches Herzzentrum Muenchen, München
Collaborators (1)
Abbott Medical Devices
INDUSTRY
SIS Medical AG
INDUSTRY
Deutsches Herzzentrum Muenchen
OTHER