Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.
Detailed description
This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents. Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.
Interventions
DEVICEdrug-eluting stent
Cypher Sirolimus-eluting Coronary Stent
DEVICEbare-metal stent
any bare-metal stent brand
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following: 1. ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal ST depression 2. New or presumably new left bundle branch block (LBBB) 2. The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;
Exclusion criteria
1. Killip class \> 2 upon arrival to the cath-lab; 2. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff; 3. Evidence of massive thrombus in the infarct related artery distally to the culprit lesion; 4. Documented left ventricular ejection fraction \<=30%; 5. Target lesion is located in an arterial or venous by-pass graft; 6. ECG documented evidence of prior myocardial infarction; 7. Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of target vessel failure (TVF) defined as target vessel revascularization, recurrent myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vesselpost-procedure. | 1 and 6 months and at 1, 3, 4, and 5 years post-procedure. |
Secondary
| Measure | Time frame |
|---|---|
| cardiac death | 1, 3, 4 and 5 years post-procedure |
| recurrence of myocardial infarction | 1, 3, 4 and 5 years post-procedure |
| revascularization of the target vessel (TVR) | 1, 3, 4 and 5 years post-procedure |
| recurrence of ischemia | 1, 3, 4 and 5 years post-procedure |
Countries
France, Germany
Outcome results
None listed