PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

Study Overview
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Brief Summary
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A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

Detailed Description
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A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

Official Title
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The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Rotational atherectomy in combination with cutting 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 (for definition see appendix) 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotational atherectomy + Cutting Balloon<br>Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions | Procedure: Rotational atherectomy in combination with cutting balloon<br>* Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Numerical in-stent acute lumen gain in mm | The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD. | At the end of the index procedure | 
| Co-primary OCT endpoint: Ratio of stent expansion index (SEI) | The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure | At the end of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical in-stent late lumen loss at 9 month follow-up angiography in mm | In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint. | 9 months follow-up | 
| Rate of angiographic success in percent | 'Angiographic 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. | Peri-procedural | 
| Rate of strategy success in percent | '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 stent failure. | Peri-procedural | 
| Rate of target vessel failure in percent | Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years. | 9 months, 1 and 2 years follow-up | 
| Rate of in-segment binary restenosis at 9 months in percent | In-segment binary restenosis at 9 months | 9 months follow-up | 
| Rate of stent thrombosis in percent | Stent thrombosis | 9 months, 1 and 2 years follow-up and final 5 years follow-up | 
| Rate of peri-procedural myocardial infarction in percent | Peri-procedural myocardial infarction | Peri-procedural | 
| Rate of vessel perforation in percent | Rate of vessel perforation | Peri-procedural | 
| Numerical procedural duration in min | Procedural duration | Peri-procedural | 
| Numerical contrast dye amount in ml | Procedural contrast dye amount | Peri-procedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcified coronary lesions