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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with calcified coronary artery disease | Patients with calcified coronary artery disease require an ICL using the Shockwave catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracoronary lithotripsy (ICL) | Other | ICL using the Shockwave catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success | Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ). | Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| MACE |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be scheduled to undergo a intracoronary lithotripsy procedure using the Shockwave catheter (Shockwave Medical, Fremont, CA).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias I Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Universitari de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30715944 | Background | 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. | |
| 31553205 |
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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 |
| Residual stenosis | Assessment of angiographic stenosis during stent implantation | Index Procedure |
| Death (all cause) | Death (all cause) | 12 months |
| Death (cardiovascular) | Death (cardiovascular) | 12 months |
| Non-fatal Myocardial Infarction | Non-fatal Myocardial Infarction | 12 months |
| Target Vessel Revascularization | Target Vessel Revascularization | 12 months |
| Stent thrombosis of target lesion | Stent thrombosis of target lesion | 12 months |
| 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 |
| 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. |
| 30765621 | Background | 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. |
| Background | 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. |
| 24846971 | Background | 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. |
| 38385926 | Derived | 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. |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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