ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
NCT ID: NCT05072730
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-12-01
2024-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Super high-pressure balloon (OPN NC)
Patients will be treated with a Super High Pressure percutaneous transluminal coronary angioplasty (PTCA) Balloon (OPN NC).
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)
Patients will be treated with intravascular lithotripsy (IVL).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Persistent angina despite medical therapy and/or evidence of inducible ischemia
* De-novo lesion in a native coronary artery
* Target reference vessel diameter or intended stent diameter ≥2.50 or ≤4.00 mm by visual estimation
* Severe calcification of the target lesion as determined by visual estimation at coronary angiography
* Unsuccessful lesion preparation with standard non-compliant balloon (\< 30% reduction of baseline diameter stenosis at maximal pressure)
* Written informed consent.
Exclusion Criteria
* Target lesion is an in-stent restenosis
* Target lesion is a chronic total occlusion
* Target vessel thrombus
* Limited long-term prognosis due to other comorbid conditions with life expectancy \<12 months
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
SIS Medical AG
INDUSTRY
Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Principal Investigators
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Salvatore Cassese, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum Munich
Tobias Rheude, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum Munich
Locations
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Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum
Bad Oeynhausen, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
MEDICLIN Herzzentrum Lahr
Lahr, , Germany
Deutsches Herzzentrum Muenchen
München, , Germany
Countries
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Central Contacts
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Facility Contacts
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Mohamed Ayoub, MD
Role: primary
David M Leistner, Prof. MD
Role: primary
Kambis Mashayekhi, MD
Role: primary
Salvatore Cassese, MD
Role: primary
References
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Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T. Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2: Design and Rationale of the ISAR-CALC 2 Trial. Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30.
Other Identifiers
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GE IDE Nr. BA00421
Identifier Type: -
Identifier Source: org_study_id
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