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

Fundación EPIC1,000 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Ischemic Heart Disease Coronary Artery Disease

Interventions

XIENCE SierraDEVICE

Percutaneous coronary intervention

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (44)

Outcomes

Primary Outcomes

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). .

Time frame: 12 month

Efficacy.The incidence of clinically driven target lesion revascularization (TLR).

The incidence of clinically driven target lesion revascularization (TLR).

Time frame: 12 month

Secondary Outcomes

All death.

All death. Systemic embolism, Major bleeding event (BARC ≥ 2)

Time frame: 12 month

Cardiac death.

Time frame: 12 month

Target Vessel revascularization.

Time frame: 12 month

Target lesion revascularization.

Time frame: 12 month

Stent thrombosis (ARC definite/probable).

Time frame: 12 month

Major bleeding event (BARC type 2-5).

Time frame: 12 month

Data from ClinicalTrials.gov

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Hospital Garcia de Orta

Almada, Portugal

Centro Hospitalar Lisboa Occidental. Hospital de Santa Cruz

Carnaxide, Portugal

Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

Espinho, Portugal

Hospital do Espírito Santo de Évora

Evora, Portugal

Hospital Do Divino Espirito Santo De Ponta Delgada

Ponta Delgada, Portugal

Hospital Do Divino Espirito Santo

Ponta Delgada, Portugal

Centro Hospitalar de Setubal, EPE - Hospital Sao Bernardo

Setúbal, Portugal

Hospital Universitario Vinalopo

Elche, Alicante, Spain

Hospital de Torrevieja

Torrevieja, Alicante, Spain

Hospital de Mérida

Mérida, Badajoz, Spain

...and 34 more locations