Arterial Occlusive Diseases, Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Vascular Diseases
Conditions
Keywords
Intracoronary lithotripsy, Calcified lesions, Percutaneous Coronary Intervention
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.
Interventions
OTHERIntracoronary lithotripsy (ICL)
ICL using the Shockwave catheter.
Sponsors
Fundación EPIC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Index Procedure | Assessment of procedural success defined as angiographic results (TIMI grade 3 and residual stenosis \< 20% without in-hospital complications ). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| Target Vessel Revascularization | 12 months | Target Vessel Revascularization |
| Stent thrombosis of target lesion | 12 months | Stent thrombosis of target lesion |
| Non-fatal Myocardial Infarction | 12 months | Non-fatal Myocardial Infarction |
Countries
Spain
Outcome results
None listed