An observational study in Cardiovascular Diseases, Arteriosclerosis and Arterial Occlusive Diseases, sponsored by Fundación EPIC. Completed at 26 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Fundación EPIC · Observational
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 426 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Fundación EPIC is the lead sponsor of 48 studies on the registry; 19 are open to participants now.
Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients will be scheduled to undergo a intracoronary lithotripsy procedure using the Shockwave catheter (Shockwave Medical, Fremont, CA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with calcified coronary artery disease require an ICL using the Shockwave catheter.
Other: Intracoronary lithotripsy (ICL)
ICL using the Shockwave catheter.
Procedural success
Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis \< 20% without in-hospital complications ).
Time frame: Index Procedure
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.
Time frame: Index Procedure
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.
Time frame: 12 months
Residual stenosis
Assessment of angiographic stenosis during stent implantation
Time frame: Index Procedure
Death (all cause)
Death (all cause)
Time frame: 12 months
Death (cardiovascular)
Death (cardiovascular)
Time frame: 12 months
Non-fatal Myocardial Infarction
Non-fatal Myocardial Infarction
Time frame: 12 months
Target Vessel Revascularization
Target Vessel Revascularization
Time frame: 12 months
Stent thrombosis of target lesion
Stent thrombosis of target lesion
Time frame: 12 months
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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