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

NCT ID: NCT00968019

Last Updated: 2013-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Coronary Arteriosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Presillion stent

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

Presillion stent

Intervention Type DEVICE

Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).

Interventions

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Presillion stent

Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No specified
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson and Johnson, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angel Cequier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Bellvitge

Locations

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Hospital Garcia Da Orta

Almada, , Portugal

Site Status

Hospital de Santa Cruz

Lisbon, , Portugal

Site Status

Hospital Sao Joao

Porto, , Portugal

Site Status

Centro Hospitalar Vila Real

Vila Real, , Portugal

Site Status

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, Spain

Site Status

Hospital Germans Trias I Pujol

Badalona, Barcelona, Spain

Site Status

Centro Medico Teknon

Barcelona, Barcelona, Spain

Site Status

Hospital de La Santa Creu I Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Capio Hospital General de Cataluña

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Universitario Arnau de Vilanova

Lleida, Lerida, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Countries

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Portugal Spain

Other Identifiers

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08-CR-001

Identifier Type: -

Identifier Source: org_study_id

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