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ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
Sponsor: Deutsches Herzzentrum Muenchen
Summary
The ISAR-CALC 2 trial is an investigator-initiated, prospective, randomized, multicenter, assessors-blind, open-label other clinical investigation. The objective of this trial is to investigate final angiographic minimal lumen diameter (MLD) following a strategy of super high-pressure balloon (OPN NC) versus intravascular lithotripsy (IVL) for drug-eluting stent (DES) implantation in severely calcified coronary lesions.
Official title: Super High-Pressure Balloon Versus Intravascular Lithotripsy for Severely Calcified Coronary Lesions: The ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC) 2 Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-12-01
Completion Date
2026-05-21
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Jena
Jena, Germany
MEDICLIN Herzzentrum Lahr
Lahr, Germany
Deutsches Herzzentrum Muenchen
München, Germany