Clinical trial NCT04298307: Registry of Coronary Lithotripsy in Spain.
Official title: Prospective, Multicenter, Observational, Single-arm Registry of Coronary Lithotripsy for the Management of Calcified Lesions in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Coronary Artery Disease
Keywords: Intracoronary lithotripsy
Calcified lesions
Percutaneous Coronary Intervention
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be scheduled to undergo a intracoronary lithotripsy procedure using the Shockwave catheter (Shockwave Medical, Fremont, CA).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural success
timeFrame: Index Procedure
Secondary outcomes:
measure: MACE
timeFrame: Index Procedure
measure: MACE
timeFrame: 12 months
measure: Residual stenosis
timeFrame: Index Procedure
measure: Death (all cause)
timeFrame: 12 months
measure: Death (cardiovascular)
timeFrame: 12 months
measure: Non-fatal Myocardial Infarction
timeFrame: 12 months
measure: Target Vessel Revascularization
timeFrame: 12 months
measure: Stent thrombosis of target lesion
timeFrame: 12 months
Other outcomes:
Locations:
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago De Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: Coruña
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
state: LA Coruña
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
state: Pontevedra
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Madrid
country: Spain
facility: Hospital La Luz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Central de La Defensa
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Tarragona
country: Spain
facility: Hospital Universitari Joan Xxiii
city: Toledo
country: Spain
facility: Hospital Universitario Virgen de La Salud de Toledo
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miquel Servet
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
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.
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.