The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.

Inclusion Criteria:

1. Clinical inclusion criteria

   • Age above 18 years and consentable
   • Angiographically proven coronary artery disease
   • Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
   • Written informed consent

2. Angiographic inclusion criteria

   • De-novo lesion in a native coronary artery
   • Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
   • Luminal diameter reduction of 50-100% by visual estimation
   • Severe calcification of the target lesion

Exclusion Criteria:

1. Clinical exclusion criteria

   • Myocardial infarction (within 1 week)
   • Decompensated heart failure
   • Limited long term prognosis due to other conditions

2. Angiographic exclusion criteria

   • Target lesion is in a coronary artery bypass graft
   • Target lesion is an in-stent restenosis
   • Target vessel thrombus