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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Intervention / Treatment
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* Device: Rotational Atherectomy
* Device: Cutting/Scoring Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: Clinical exclusion criteria Myocardial infarction (within 1 week) Decompensated heart failure Limited long term prognosis due to other conditions Angiographic exclusion criteria Target lesion is in a coronary artery bypass graft Target lesion is an in-stent restenosis Target vessel thrombus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotational Atherectomy<br>Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent | Device: Rotational Atherectomy<br>* Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent<br>|
| Active Comparator: Cutting/Scoring Balloon<br>Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent | Device: Cutting/Scoring Balloon<br>* Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strategy Success | The primary endpoint will be 'Strategy Success' defined as successful stent delivery and expansion with attainment of < 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without crossover or stent failure | Intraprocedural | 
| In-Stent late lumen loss at 9 months | Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) | Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI; Q- or non-Q-wave) and clinically driven target vessel revascularization (TVR) at 9 months, 1 and 2 years | 9 months, 1 year, 2 years | 
| In-segment late lumen loss at 9 months | In-segment late lumen loss (stent length + 5 mm on either side) at 9 months | 9 months | 
| In-segment binary restenosis at 9 months | In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months | 9 months | 
| Stent thrombosis at 9 months, 1 and 2 years | Stent thrombosis at 9 months, 1 and 2 years | 9 months, 1 and 2 years | 
| Peri-procedural MI |  | within 72 hrs | 
| Procedural duration |  | Intraproedural | 
| Amount of contrast dye |  | Intraprocedural |