Registry of Coronary Lithotripsy in Spain.

Study Overview
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Brief Summary
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The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.

Detailed Description
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The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation.

Official Title
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Prospective, Multicenter, Observational, Single-arm Registry of Coronary Lithotripsy for the Management of Calcified Lesions in Spain.

Conditions
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Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease

Intervention / Treatment
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* Other: Intracoronary lithotripsy (ICL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age. Patients with calcified coronary artery disease requiring percutaneous revascularization with stent implantation who, at the operator's discretion and according to the hospital routine clinical practice, require an ICL with the Shockwave catheter. The patients have been informed of the study characteristics and have given their written informed consent. Exclusion Criteria: Refusal to participate in this study. Patients whose life expectancy is < 1 year. Patients with hemodynamic instability with Killip class III or IV.

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 |
| --- | --- |
| Patients with calcified coronary artery disease<br>Patients with calcified coronary artery disease require an ICL using the Shockwave catheter. | Other: Intracoronary lithotripsy (ICL)<br>* ICL using the Shockwave catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ). | Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | Major Cardiovascular Adverse Events (MACE), defined as a composite of cardiac death, target vessel related nonfatal infarction or need for unplanned target vessel revascularization during hospital admission. | Index Procedure | 
| MACE | Major Cardiovascular Adverse Events (MACE), defined as a composite of cardiac death, target vessel related nonfatal infarction or need for unplanned target vessel revascularization. | 12 months | 
| Residual stenosis | Assessment of angiographic stenosis during stent implantation | Index Procedure | 
| Death (all cause) | Death (all cause) | 12 months | 
| Death (cardiovascular) | Death (cardiovascular) | 12 months | 
| Non-fatal Myocardial Infarction | Non-fatal Myocardial Infarction | 12 months | 
| Target Vessel Revascularization | Target Vessel Revascularization | 12 months | 
| Stent thrombosis of target lesion | Stent thrombosis of target lesion | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracoronary lithotripsy, Calcified lesions, Percutaneous Coronary Intervention