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

This study has been completed.

First Received on August 27, 2009. Last Updated on July 5, 2011 History of Changes

Sponsor:	Johnson and Johnson, S.A.
Information provided by:	Johnson and Johnson, S.A.
ClinicalTrials.gov Identifier:	NCT00968019

Purpose

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

Condition
Coronary Angioplasty

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by Johnson and Johnson, S.A.:

Primary Outcome Measures:

Major Cardiac Adverse Events (including cardiac death, imyocardial infarction (Q-wave and non Q-wave) and clinically driven TLR (target lesion revascularization)) [ Time Frame: at 12 months follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	314
Study Start Date:	April 2009
Study Completion Date:	May 2011

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

Detailed Description:

Primary endopoint: 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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968019

Locations

Portugal
Hospital Garcia Da Orta
Almada, Portugal, 2805-951
Hospital de Santa Cruz
Lisbon, Portugal, 2799-523
Hospital Sao Joao
Porto, Portugal, 4200-319
Centro Hospitalar Vila Real
Vila Real, Portugal, 5000 - 508
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Capio Hospital General de Cataluña
Sant Cugat del Valles, Barcelona, Spain, 08195
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Complejo Hospitalario Universitario de Albacete
Albacete, Spain, 02006
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Centro Medico Teknon
Barcelona, Spain, 08022
Hospital Universitario Arnau de Vilanova
Lerida, Spain, 25198

Sponsors and Collaborators

Johnson and Johnson, S.A.

Investigators

Principal Investigator:

Angel Cequier, MD, PhD

Hospital Universitario de Bellvitge

More Information

No publications provided

Responsible Party:	Mayda Lopez-Belmonte / Clinical Affairs Manager, Johnson and Johnson Medical Iberia
ClinicalTrials.gov Identifier:	NCT00968019 History of Changes
Other Study ID Numbers:	08-CR-001
Study First Received:	August 27, 2009
Last Updated:	July 5, 2011
Health Authority:	Spain: Ethics Committee; Portugal: Ethics Committees

ClinicalTrials.gov processed this record on February 09, 2012