Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

Completed

Conditions: Coronary Arteriosclerosis

Interventions: Device: Presillion stent

Registration Number: NCT00968019

Lead Sponsor: Johnson and Johnson, S.A.

Brief Summary: The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 318

Inclusion Criteria

All subjects treated with Presillion stent up to two de novo coronary artery lesions

Exclusion Criteria

No specified

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Presillion stent	Presillion stent	Patients treated with the Presillion stent in up to two de novo coronary artery lesions

Primary Outcome Measures

Name	Time	Method
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))	at 12 months follow-up	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%).

Secondary Outcome Measures

Name	Time	Method
Stroke	Up to 12 months
Lesion Success	Peri-procedure up to discharge	Lesion success defined as the attainment of \<50% final diameter stenosis (by visual estimate) using any percutaneous method.
Clinically Driven TLR	up to 12 months	Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel
Target Vessel Failure	Up to 12 months	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.
Major Bleeding	Up to 12 months
Device Success	Peri-procedure up to discharge	Device success defined as achievement of a final diameter stenosis of \<50% (by visual estimate), using the assigned device only
Clinically Driven TVR	Up to 12 months	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.
Stent Thrombosis	Up to 12 months	Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.
Procedural Success	Peri-procedure up to discharge	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
Myocardial Infarction	Up to 12 months	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

Trial Locations

Locations (13): Hospital Garcia Da Orta
🇵🇹
Almada, Portugal
Hospital Universitario Central de Asturias
🇪🇸
Oviedo, Asturias, Spain
Centro Hospitalar Vila Real
🇵🇹
Vila Real, Portugal
Hospital de Santa Cruz
🇵🇹
Lisbon, Portugal
Hospital Sao Joao
🇵🇹
Porto, Portugal
Hospital Germans Trias I Pujol
🇪🇸
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
🇪🇸
Hospitalet de Llobregat, Barcelona, Spain
Capio Hospital General de Cataluña
🇪🇸
Sant Cugat del Valles, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸
Santander, Cantabria, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸
Albacete, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸
Lerida, Spain
Centro Medico Teknon
🇪🇸
Barcelona, Spain
Hospital de La Santa Creu I Sant Pau
🇪🇸
Barcelona, Spain