REPLICA: Registry of Coronary Lithotripsy in Spain.

Sponsor

Fundación EPIC (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04298307

Collaborator

(none)

400

Enrollment

Locations

53.9

Anticipated Duration (Months)

15.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Coronary Artery Disease	Other: Intracoronary lithotripsy (ICL)

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 4, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with calcified coronary artery disease Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.	Other: Intracoronary lithotripsy (ICL) ICL using the Shockwave catheter.

Arm

Intervention/Treatment

Patients with calcified coronary artery disease

Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.

Other: Intracoronary lithotripsy (ICL)

ICL using the Shockwave catheter.

Outcome Measures

Primary Outcome Measures

Procedural success [Index Procedure]
Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ).

Secondary Outcome Measures

MACE [Index Procedure]
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.
MACE [12 months]
Major Cardiovascular Adverse Events (MACE), defined as a composite of cardiac death, target vessel related nonfatal infarction or need for unplanned target vessel revascularization.
Residual stenosis [Index Procedure]
Assessment of angiographic stenosis during stent implantation
Death (all cause) [12 months]
Death (all cause)
Death (cardiovascular) [12 months]
Death (cardiovascular)
Non-fatal Myocardial Infarction [12 months]
Non-fatal Myocardial Infarction
Target Vessel Revascularization [12 months]
Target Vessel Revascularization
Stent thrombosis of target lesion [12 months]
Stent thrombosis of target lesion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario de Cabueñes	Gijón	Asturias	Spain	33394
2	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33011
3	Hospital Universitari Germans Trias I Pujol	Badalona	Barcelona	Spain	08916
4	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona	Spain	08907
5	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona	Spain	08221
6	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
7	Hospital Clinico Universitario de Santiago de Compostela	Santiago De Compostela	Coruña	Spain	15706
8	Hospital Universitario A Coruña	A Coruña	LA Coruña	Spain	15006
9	Hospital Universitario Alvaro Cunqueiro	Vigo	Pontevedra	Spain	36213
10	Hospital General Universitario de Albacete	Albacete		Spain	02006
11	Hospital Universitario de Badajoz	Badajoz		Spain	06080
12	Hospital General Universitario de Ciudad Real	Ciudad Real		Spain	13005
13	Hospital de León	León		Spain	24080
14	Hospital Universitario Lucus Agusti	Lugo		Spain	27003
15	Hospital La Luz	Madrid		Spain	28003
16	Hospital Universitario La Princesa	Madrid		Spain	28006
17	Hospital Clinico San Carlos	Madrid		Spain	28040
18	Hospital Universitario La Paz	Madrid		Spain	28046
19	Hospital Central de La Defensa	Madrid		Spain	28047
20	Hospital Universitario Puerta de Hierro	Majadahonda		Spain	28222
21	Hospital Universitario de Salamanca	Salamanca		Spain	37007
22	Hospital Universitario Donostia	San Sebastián		Spain	20014
23	Hospital Universitari Joan Xxiii	Tarragona		Spain	43005
24	Hospital Universitario Virgen de La Salud de Toledo	Toledo		Spain	45004
25	Hospital Clinico Universitario de Valladolid	Valladolid		Spain	47003
26	Hospital Universitario Miquel Servet	Zaragoza		Spain	50009