The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
Primary endpoint: Composite of Major Adverse Cardiac Events (MACE), which includes cardiac death, myocardial infarction (Q-wave and non Q-wave) and clinically driven target lesion revascularization (TLR) at 12 months follow-up. Data will be collected on 400 patients (from 14 hospitals in Spain and Portugal) treated with the Presillion stent in up to 2 de novo native coronary artery lesions Study design: multicenter, prospective, observational
Study Type
OBSERVATIONAL
Enrollment
318
Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).
Hospital Garcia Da Orta
Almada, Portugal
Hospital de Santa Cruz
Lisbon, Portugal
Hospital Sao Joao
Porto, Portugal
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR). The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).
Time frame: at 12 months follow-up
Device Success
Device success defined as achievement of a final diameter stenosis of \<50% (by visual estimate), using the assigned device only
Time frame: Peri-procedure up to discharge
Lesion Success
Lesion success defined as the attainment of \<50% final diameter stenosis (by visual estimate) using any percutaneous method.
Time frame: Peri-procedure up to discharge
Procedural Success
Procedural success defined as achievement of a final diameter stenosis of \<50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay
Time frame: Peri-procedure up to discharge
Clinically Driven TLR
Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
Time frame: Up to 30 days
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Centro Hospitalar Vila Real
Vila Real, Portugal
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, Spain
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain
Centro Medico Teknon
Barcelona, Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Capio Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, Spain
...and 3 more locations
Clinically Driven TVR
Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Time frame: Up to 30 days
Target Vessel Failure
Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel. Target vessel failure will be reported when: 1. MI occurs in territory not clearly attributed to a vessel other than the target vessel. 2. Cardiac death not clearly due to a non-target vessel endpoint. 3. Target vessel revascularization is performed.
Time frame: Up to 30 days
Myocardial Infarction
A positive diagnosis of myocardial infarction is made when one of the following criteria is met: 1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following: * ischemic symptoms * ECG changes indicative of ischemia (ST segment elevation or depression) * Development of pathological Q waves in the ECG * Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality 2. Pathological findings of an acute myocardial infarction
Time frame: Up to 30 days
Major Bleeding
Time frame: Up to 30 days
Stroke
Time frame: Up to 30 days
Stent Thrombosis
Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
Time frame: Up to 30 days
Clinically Driven TLR
Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
Time frame: up to 12 months
Clinically Driven TVR
Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Time frame: Up to 12 months
Target Vessel Failure
Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel. Target vessel failure will be reported when: 1. MI occurs in territory not clearly attributed to a vessel other than the target vessel. 2. Cardiac death not clearly due to a non-target vessel endpoint. 3. Target vessel revascularization is performed.
Time frame: Up to 12 months
Myocardial Infarction
A positive diagnosis of myocardial infarction is made when one of the following criteria is met: 1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following: * ischemic symptoms * ECG changes indicative of ischemia (ST segment elevation or depression) * Development of pathological Q waves in the ECG * Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality 2. Pathological findings of an acute myocardial infarction
Time frame: Up to 12 months
Major Bleeding
Time frame: Up to 12 months
Stent Thrombosis
Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
Time frame: Up to 12 months
Stroke
Time frame: Up to 12 months