Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
426 participants
OBSERVATIONAL
2020-05-04
2023-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with calcified coronary artery disease
Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.
Intracoronary lithotripsy (ICL)
ICL using the Shockwave catheter.
Interventions
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Intracoronary lithotripsy (ICL)
ICL using the Shockwave catheter.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients whose life expectancy is \< 1 year.
* Patients with hemodynamic instability with Killip class III or IV.
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, Coruña, Spain
Hospital Universitario A Coruña
A Coruña, LA Coruña, Spain
Hospital Universitario Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario de Albacete
Albacete, , Spain
Hospital Universitario de Badajoz
Badajoz, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital de León
León, , Spain
Hospital Universitario Lucus Agusti
Lugo, , Spain
Hospital La Luz
Madrid, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Central de La Defensa
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital Universitari Joan Xxiii
Tarragona, , Spain
Hospital Universitario Virgen de La Salud de Toledo
Toledo, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario Miquel Servet
Zaragoza, , Spain
Countries
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References
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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.
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.
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. doi: 10.25270/jic/19.00048. Epub 2019 Feb 15.
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.
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.
Rodriguez-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.
Other Identifiers
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EPIC18-REPLICA
Identifier Type: -
Identifier Source: org_study_id
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