Registry of Coronary Lithotripsy in Spain.
REPLICA
Prospective, Multicenter, Observational, Single-arm Registry of Coronary Lithotripsy for the Management of Calcified Lesions in Spain.
1 other identifier
observational
426
1 country
26
Brief Summary
The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedJune 15, 2025
July 1, 2022
3.1 years
February 26, 2020
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Procedural success
Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis \< 20% without in-hospital complications ).
Index Procedure
Secondary Outcomes (8)
MACE
Index Procedure
MACE
12 months
Residual stenosis
Index Procedure
Death (all cause)
12 months
Death (cardiovascular)
12 months
- +3 more secondary outcomes
Study Arms (1)
Patients with calcified coronary artery disease
Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.
Interventions
ICL using the Shockwave catheter.
Eligibility Criteria
Patients will be scheduled to undergo a intracoronary lithotripsy procedure using the Shockwave catheter (Shockwave Medical, Fremont, CA).
You may qualify if:
- 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.
You may not qualify if:
- Refusal to participate in this study.
- Patients whose life expectancy is \< 1 year.
- Patients with hemodynamic instability with Killip class III or IV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación EPIClead
Study Sites (26)
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Coruña, 15706, Spain
Hospital Universitario A Coruña
A Coruña, LA Coruña, 15006, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Pontevedra, 36213, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, 33394, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital General Universitario de Albacete
Albacete, 02006, Spain
Hospital Universitario de Badajoz
Badajoz, 06080, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005, Spain
Hospital de León
León, 24080, Spain
Hospital Universitario Lucus Agusti
Lugo, 27003, Spain
Hospital La Luz
Madrid, 28003, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Central de La Defensa
Madrid, 28047, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, 28222, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Donostia
San Sebastián, 20014, Spain
Hospital Universitari Joan Xxiii
Tarragona, 43005, Spain
Hospital Universitario Virgen de La Salud de Toledo
Toledo, 45004, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Hospital Universitario Miquel Servet
Zaragoza, 50009, Spain
Related Publications (6)
Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Gotberg 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. No abstract available.
PMID: 30715944BACKGROUNDAli 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.
PMID: 31553205BACKGROUNDWong 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. doi: 10.25270/jic/19.00048. Epub 2019 Feb 15.
PMID: 30765621BACKGROUNDVilalta 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.
BACKGROUNDBourantas 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.
PMID: 24846971BACKGROUNDRodriguez-Leor O, Cid-Alvarez AB, Lopez-Benito M, Gonzalo N, Vilalta V, Diarte de Miguel JA, Lopez LF, Jurado-Roman A, Diego A, Oteo JF, Cuellas C, Trillo R, Travieso A, Alfonso F, Carrillo X, Vegas-Valle JM, Cortes-Villar C, Pascual I, Munoz Camacho JF, Flores X, Vera-Vera S, Moreu J, Barreira de Sousa G, Marti D, Jimenez-Mazuecos J, Fuertes M, Ocaranza R, de la Torre Hernandez JM, Lozano F, Solana Martinez SG, Gomez-Lara J, Perez de Prado A; REPLICA-EPIC18 Investigators. A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries: The REPLICA-EPIC18 Study. JACC Cardiovasc Interv. 2024 Mar 25;17(6):756-767. doi: 10.1016/j.jcin.2023.12.018. Epub 2024 Feb 21.
PMID: 38385926DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2020
First Posted
March 6, 2020
Study Start
May 4, 2020
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
June 15, 2025
Record last verified: 2022-07