Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

Study Overview
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Brief Summary
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This prospective registry is intended to evaluate the safety and efficacy of the XIENCE Sierra stent.

Detailed Description
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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).

Official Title
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Prospective Registry of Patients Over 75 Years Old Treated With Xience Sierra Stents. Sierra 75 Study

Conditions
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Ischemic Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: XIENCE Sierra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary Artery Disease<br>Drug- eluting Stent | Device: XIENCE Sierra<br>* Percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). . | The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable). . | 12 month | 
| Efficacy.The incidence of clinically driven target lesion revascularization (TLR). | The incidence of clinically driven target lesion revascularization (TLR). | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death. | All death. Systemic embolism, Major bleeding event (BARC ≥ 2) | 12 month | 
| Cardiac death. | Cardiac death. | 12 month | 
| Target Vessel revascularization. | Target Vessel revascularization. | 12 month | 
| Target lesion revascularization. | Target lesion revascularization. | 12 month | 
| Stent thrombosis (ARC definite/probable). | Stent thrombosis (ARC definite/probable). | 12 month | 
| Major bleeding event (BARC type 2-5). | Major bleeding event (BARC type 2-5). | 12 month | 
| Stroke. | Stroke. | 12 month | 
| Procedural success. | Procedural success ( Residual stenosis <30% after implantation at the narrowest point of the treated vascular segment). | 12 month | 
| Rate of patients with DAPT. | Rate of patients with DAPT. | 1 month | 
| Rate of patients with DAPT. | Rate of patients with DAPT. | From 1 to 3 months | 
| Rate of patients with DAPT. | Rate of patients with DAPT. | From 3 to 6 months | 
| Rate of patients with DAPT. | Rate of patients with DAPT. | From 6 to 12 months | 
| Collection of imaging data by Optical coherence tomography (OCT). | Collection of imaging data by OCT. | 12 month | 
| Collection of imaging data by Intravascular Ultrasound (IVUS). | Collection of imaging data by IVUS. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dual antiplatelet treatment, Elderly patients