Registry of Coronary Lithotripsy in Spain.

Coronary Artery Disease Clinical Trial

— REPLICA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298307
• Other study ID #: EPIC18-REPLICA
• Status: Active, not recruiting
• Start date: May 4, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: July 2022
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Vascular Diseases

Intervention

Other:
• Intracoronary lithotripsy (ICL)
ICL using the Shockwave catheter.

Locations

Country	Name	City	State
Spain	Hospital Universitario A Coruña	A Coruña	LA Coruña
Spain	Hospital General Universitario de Albacete	Albacete
Spain	Hospital Universitario de Badajoz	Badajoz
Spain	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital Universitario de Cabueñes	Gijón	Asturias
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital de León	León
Spain	Hospital Universitario Lucus Agusti	Lugo
Spain	Hospital Central de La Defensa	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital La Luz	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Donostia	San Sebastián
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela	Coruña
Spain	Hospital Universitari Joan Xxiii	Tarragona
Spain	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario Virgen de La Salud de Toledo	Toledo
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Alvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Universitario Miquel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25. — View Citation

Bourantas CV, Zhang YJ, Garg S, Iqbal J, Valgimigli M, Windecker S, Mohr FW, Silber S, Vries Td, Onuma Y, Garcia-Garcia HM, Morel MA, Serruys PW. Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. Heart. 2014 Aug;100(15):1158-64. doi: 10.1136/heartjnl-2013-305180. Epub 2014 May 20. — View Citation

Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Götberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531. — View Citation

Vilalta V, Rodriguez-Leor O, Cid-Alvarez B, et al. Intracoronary Lithotripsy in a High-risk Real-world Population: First Experience in Severely Calcified, Complex Coronary Lesions. REC Interv Cardiol 2019; in press.

Wong B, El-Jack S, Newcombe R, Glenie T, Armstrong G, Khan A. Shockwave Intravascular Lithotripsy for Calcified Coronary Lesions: First Real-World Experience. J Invasive Cardiol. 2019 Mar;31(3):46-48. Epub 2019 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ).	Index Procedure
Secondary	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
Secondary	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
Secondary	Residual stenosis	Assessment of angiographic stenosis during stent implantation	Index Procedure
Secondary	Death (all cause)	Death (all cause)	12 months
Secondary	Death (cardiovascular)	Death (cardiovascular)	12 months
Secondary	Non-fatal Myocardial Infarction	Non-fatal Myocardial Infarction	12 months
Secondary	Target Vessel Revascularization	Target Vessel Revascularization	12 months
Secondary	Stent thrombosis of target lesion	Stent thrombosis of target lesion	12 months