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Completed
NCT05072730
ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2
Conditions: Calcified Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Deutsches Herzzentrum Muenchen
Location: Herz- und Diabeteszentrum NRW Universitätsklinikum der Ruhr-Universität Bochum Bad Oeynhausen
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.
Eligibility Criteria
Inclusion Criteria:
* Age above 18 years and able to give consent
* 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 located in a coronary artery bypass graft
* 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 \
Source: ClinicalTrials.gov (NCT05072730). StuddyBuddy aggregates publicly available trial information.