Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
Dual antiplatelet treatment, Elderly patients
Brief summary
This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.
Detailed description
This prospective registry is intended to analyze clinical outcomes in elderly patients treated with XIENCE Sierra stent and in pre-established subgroups (stable and unstable coronary artery disease).
Interventions
DEVICEXIENCE Sierra
Percutaneous coronary intervention
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\> 75 years. * With indication of percutaneous revascularization. * Presence of de novo coronary artery lesions located in a native coronary artery. * Informed consent signed
Exclusion criteria
* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention) * Cardiac arrest before the PCI * Life expectancy of the patient under 1 year * Participation in another study with a drug or device in clinical research * Clinical decision that excludes the use of drug-eluting stents * Confirmed allergy to aspirin and / or thienopyridines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). . | 12 month | The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). . |
| Efficacy.The incidence of clinically driven target lesion revascularization (TLR). | 12 month | The incidence of clinically driven target lesion revascularization (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel revascularization. | 12 month | Target Vessel revascularization. |
| Target lesion revascularization. | 12 month | Target lesion revascularization. |
| Stent thrombosis (ARC definite/probable). | 12 month | Stent thrombosis (ARC definite/probable). |
| Major bleeding event (BARC type 2-5). | 12 month | Major bleeding event (BARC type 2-5). |
| All death. | 12 month | All death. Systemic embolism, Major bleeding event (BARC ≥ 2) |
| Procedural success. | 12 month | Procedural success ( Residual stenosis \<30% after implantation at the narrowest point of the treated vascular segment). |
| Rate of patients with DAPT. | 1 month | Rate of patients with DAPT. |
| Collection of imaging data by Optical coherence tomography (OCT). | 12 month | Collection of imaging data by OCT. |
| Collection of imaging data by Intravascular Ultrasound (IVUS). | 12 month | Collection of imaging data by IVUS. |
| Stroke. | 12 month | Stroke. |
| Cardiac death. | 12 month | Cardiac death. |
Countries
Portugal, Spain
Outcome results
None listed