NCT00968019

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 318 (actual)
• Sponsor: Johnson and Johnson, S.A. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	Presillion stent	Centers will use commercially available Presillion Stents as recommended according to the Instruction For Use (IFU).

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2009-08-28
• Last updated: 2013-03-13
• Results posted: 2013-03-06

Locations

13 sites across 2 countries: Portugal, Spain