Registry of Coronary Lithotripsy in Spain.

Active, not recruiting

• Conditions: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Artery Disease
• Interventions: Other: Intracoronary lithotripsy (ICL)

• Registration Number: NCT04298307
• Lead Sponsor: Fundación EPIC

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2020-05-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-07
• Primary Completion: 2023-06-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with calcified coronary artery disease	Intracoronary lithotripsy (ICL)	Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Hospital Universitario de Cabueñes; 🇪🇸 Gijón, Asturias, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Clinico Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Coruña, Spain

Hospital de León; 🇪🇸 León, Spain

Hospital Universitario de Badajoz; 🇪🇸 Badajoz, Spain

Hospital Universitario A Coruña; 🇪🇸 A Coruña, LA Coruña, Spain

Hospital General Universitario de Albacete; 🇪🇸 Albacete, Spain

Hospital Universitario Alvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain

Hospital General Universitario de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital La Luz; 🇪🇸 Madrid, Spain

Hospital Universitari Joan Xxiii; 🇪🇸 Tarragona, Spain

Hospital Universitario Virgen de La Salud de Toledo; 🇪🇸 Toledo, Spain

Hospital Universitario Miquel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitario Donostia; 🇪🇸 San Sebastián, Spain

Hospital Universitario Mutua de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Central de La Defensa; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Barcelona, Spain