Status:
COMPLETED
Registry of Coronary Lithotripsy in Spain.
Lead Sponsor:
Fundación EPIC
Conditions:
Cardiovascular Diseases
Arteriosclerosis
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- Refusal to participate in this study.
- Patients whose life expectancy is \< 1 year.
- Patients with hemodynamic instability with Killip class III or IV.
Key Trial Info
Start Date :
May 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT04298307
Start Date
May 4 2020
End Date
August 1 2023
Last Update
June 15 2025
Active Locations (26)
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1
Hospital Universitari Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
4
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008