Comparison of Coronary Lithoplasty and Rotablation

Study Overview
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Brief Summary
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This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.

Detailed Description
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Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.

Official Title
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Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial

Conditions
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Coronary Artery Disease, Calcified Atheroma

Intervention / Treatment
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* Procedure: Rotablation
* Procedure: Coronary Lithoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 yrs Stable coronary heart disease or acute coronary syndromes Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel. Written informed consent was obtained before the procedure Severely calcified coronary lesion with indication for rotablation Exclusion Criteria: Known renal insufficiency (serum creatinine clearance <30ml/min/1.73m² or receiving dialysis) Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy Cardiogenic shock Lesion length > 32mm Bifurcation lesions requiring 2-Stent-Strategies

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotablation<br> | Procedure: Rotablation<br>* Percutaneous Coronary Intervention using Rotablation<br>|
| Experimental: Coronary Lithoplasty<br> | Procedure: Coronary Lithoplasty<br>* Percutaneous Coronary Intervention using Lithoplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Stent Area (End of the Procedure) |  | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal/Mean/Maximal Stent Diameter |  | 0 days | 
| Minimal/Mean/Maximal Lumen area |  | 0 days | 
| Minimal/Mean/Maximal Lumen diameter |  | 0 days | 
| Mean/Maximal Stent area |  | 0 days | 
| Incidence of target lesion failure |  | 0 months; 1 month; 6 months | 
| Incidence of target vessel failure |  | 0 months; 1 month; 6 months | 
| MACE rate |  | 0 months; 1 month; 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography