Registry of Coronary Lithotripsy in Spain.

Fundación EPIC426 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

426

Conditions

Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Coronary Artery Disease

Interventions

Intracoronary lithotripsy (ICL)OTHER

ICL using the Shockwave catheter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

Hospital Universitari Germans Trias I Pujol

Outcomes

Primary Outcomes

Procedural success

Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis \< 20% without in-hospital complications ).

Time frame: Index Procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 12 months

Residual stenosis

Assessment of angiographic stenosis during stent implantation

Time frame: Index Procedure

Death (all cause)

Time frame: 12 months

Death (cardiovascular)

Time frame: 12 months

Non-fatal Myocardial Infarction

Time frame: 12 months

Target Vessel Revascularization

Time frame: 12 months

Data from ClinicalTrials.gov

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