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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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05072730). StuddyBuddy aggregates publicly available trial information.