Clinical trial NCT00968019: Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
Official title: A Multicenter Postmarket Surveillance Registry Evaluating the Performance and Long Term Safety of the Presillion Stent in de Novo Native Coronary Artery Lesions. Iberian Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Lead sponsor: Johnson and Johnson, S.A.
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 318
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All sujects treated with Presillion stent up to two de novo coronary artery lesions

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No specified

Primary outcomes:
measure: Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))
timeFrame: at 12 months follow-up
Secondary outcomes:
measure: Device Success
timeFrame: Peri-procedure up to discharge
measure: Lesion Success
timeFrame: Peri-procedure up to discharge
measure: Procedural Success
timeFrame: Peri-procedure up to discharge
measure: Clinically Driven TLR
timeFrame: Up to 30 days
measure: Clinically Driven TVR
timeFrame: Up to 30 days
measure: Target Vessel Failure
timeFrame: Up to 30 days
measure: Myocardial Infarction
timeFrame: Up to 30 days
measure: Major Bleeding
timeFrame: Up to 30 days
measure: Stroke
timeFrame: Up to 30 days
measure: Stent Thrombosis
timeFrame: Up to 30 days
measure: Clinically Driven TLR
timeFrame: up to 12 months
measure: Clinically Driven TVR
timeFrame: Up to 12 months
measure: Target Vessel Failure
timeFrame: Up to 12 months
measure: Myocardial Infarction
timeFrame: Up to 12 months
measure: Major Bleeding
timeFrame: Up to 12 months
measure: Stent Thrombosis
timeFrame: Up to 12 months
measure: Stroke
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Almada
country: Portugal
facility: Hospital Garcia Da Orta
city: Lisbon
country: Portugal
facility: Hospital de Santa Cruz
city: Porto
country: Portugal
facility: Hospital Sao Joao
city: Vila Real
country: Portugal
facility: Centro Hospitalar Vila Real
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Capio Hospital General de Cataluña
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Lerida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
Study officials:
affiliation: Hospital Universitario de Bellvitge
name: Angel Cequier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: