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| 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: | Cohort, 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 |
| Estimated Enrollment: | 220 |
| Study Start Date: | April 2009 |
| Groups/Cohorts |
|---|
|
treated with Presillion stent
Patients treated with the Presillion stent in up to two de novo coronary artery lesions
|
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 |
All sujects treated with Presillion stent up to two de novo coronary artery lesions
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mayda Lopez-Belmonte, PhD | +34917228481 | tlopezbe@its.jnj.com |
| Portugal | |
| Hospital De Santa Cruz | Recruiting |
| Lisbon, Portugal, 2799-523 | |
| Contact: Luis Raposo, MD | |
| Principal Investigator: Luis Raposo, MD | |
| Centro Hospitalar Vila Real | Recruiting |
| Vila Real, Portugal, 5000 - 508 | |
| Contact: Henrique Carvalho, MD, PhD | |
| Principal Investigator: Henrique Carvalho, MD, PhD | |
| Hospital Garcia Da Orta | Recruiting |
| Almada, Portugal, 2805-951 | |
| Contact: Helder Pereira, MD, PhD | |
| Principal Investigator: Helder Pereira, MD, PhD | |
| Hospital Sao Joao | Recruiting |
| Porto, Portugal, 4200-319 | |
| Contact: Joao Carlos Silva, MD, PhD | |
| Principal Investigator: Joao Carlos Silva, MD, PhD | |
| Spain | |
| Complejo Hospitalario Universitario De Albacete | Recruiting |
| Albacete, Spain, 02006 | |
| Contact: Jesus Jimenez, MD, PhD | |
| Principal Investigator: Jesus Jimenez, MD, PhD | |
| Hospital De La Santa Creu I Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Joan Garcia, MD, PhD | |
| Principal Investigator: Joan Garcia, MD, PhD | |
| Centro Medico Teknon | Recruiting |
| Barcelona, Spain, 08022 | |
| Contact: Antoni Serra, MD, PhD | |
| Principal Investigator: Antoni Serra, MD, PhD | |
| Hospital Universitario Arnau De Vilanova | Recruiting |
| Lerida, Spain, 25198 | |
| Contact: Rosario Ortas, MD, PhD | |
| Principal Investigator: Rosario Ortas, MD, PhD | |
| Spain, Asturias | |
| Hospital Universitario Central De Asturias | Recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Contact: Iñigo Lozano, MD, PhD | |
| Principal Investigator: Iñigo Lozano, MD, PhD | |
| Spain, Barcelona | |
| Hospital Universitario de Bellvitge | Recruiting |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Contact: Angel Cequier, MD, PhD | |
| Principal Investigator: Angel Cequier, MD, PhD | |
| Hospital Germans Trias I Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Fina Mauri, MD, PhD | |
| Principal Investigator: Fina Mauri, MD, PhD | |
| Capio Hospital General De CATALUÑA | Active, not recruiting |
| Sant Cugat Del Valles, Barcelona, Spain, 08195 | |
| Spain, Cantabria | |
| Hospital Universitario Marques De Valdecilla | Recruiting |
| Santander, Cantabria, Spain, 39008 | |
| Contact: Javier Zueco, MD, PhD | |
| Principal Investigator: Javier Zueco, MD, PhD | |
| Principal Investigator: | Angel Cequier, MD, PhD | Hospital Universitario de Bellvitge |
More Information
| Responsible Party: | Johnson and Johnson Medical Iberia ( Mayda Lopez-Belmonte / Clinical Affairs Manager ) |
| Study ID Numbers: | 08-CR-001 |
| Study First Received: | August 27, 2009 |
| Last Updated: | January 29, 2010 |
| ClinicalTrials.gov Identifier: | NCT00968019 History of Changes |
| Health Authority: | Spain: Ethics Committee; Portugal: Ethics Committees |
