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

Segeberger Kliniken GmbH

Status: Completed

Conditions: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Treatments: Device: Rotational Atherectomy; Device: Cutting/Scoring Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02502851

SK 108 -- 120/14

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Rotational Atherectomy

Active Comparator group

Description:

Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent

Treatment:

Device: Rotational Atherectomy

Cutting/Scoring Balloon

Active Comparator group

Description:

Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent

Treatment:

Device: Cutting/Scoring Balloon