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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Coronary Arteriosclerosis

Treatments: Device: Presillion stent

Study type: Observational

Funder types: Industry

Identifiers

NCT00968019

08-CR-001

Details and patient eligibility

About

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

Full 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

Enrollment: 318 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No specified

Trial design

318 participants in 1 patient group

Presillion stent

Description:

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

Treatment:

Device: Presillion stent