ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2

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

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.

Detailed information is provided elsewhere.

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 <12 months