Registry of Coronary Lithotripsy in Spain. (REPLICA)

June 13, 2025 updated by: Fundación EPIC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

426

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario de Albacete
      • Badajoz, Spain, 06080
        • Hospital Universitario de Badajoz
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real
      • León, Spain, 24080
        • Hospital de Leon
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Agustí
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28003
        • Hospital La Luz
      • Madrid, Spain, 28047
        • Hospital Central de La Defensa
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • San Sebastián, Spain, 20014
        • Hospital Universitario Donostia
      • Tarragona, Spain, 43005
        • Hospital Universitari Joan XXIII
      • Toledo, Spain, 45004
        • Hospital Universitario Virgen de La Salud de Toledo
      • Valladolid, Spain, 47003
        • Hospital Clinico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miquel Servet
    • Asturias
      • Gijón, Asturias, Spain, 33394
        • Hospital Universitario de Cabueñes
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitario Mutua de Terrassa
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Coruña
      • Santiago De Compostela, Coruña, Spain, 15706
        • Hospital Clínico Universitario de Santiago de Compostela
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Hospital Universitario A Coruna
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • Hospital Universitario Alvaro Cunqueiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: Index Procedure
Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis < 20% without in-hospital complications ).
Index Procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 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.
Index Procedure
MACE
Time Frame: 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.
12 months
Residual stenosis
Time Frame: Index Procedure
Assessment of angiographic stenosis during stent implantation
Index Procedure
Death (all cause)
Time Frame: 12 months
Death (all cause)
12 months
Death (cardiovascular)
Time Frame: 12 months
Death (cardiovascular)
12 months
Non-fatal Myocardial Infarction
Time Frame: 12 months
Non-fatal Myocardial Infarction
12 months
Target Vessel Revascularization
Time Frame: 12 months
Target Vessel Revascularization
12 months
Stent thrombosis of target lesion
Time Frame: 12 months
Stent thrombosis of target lesion
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC18-REPLICA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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