Drug-Eluting Balloon vs Conventional Balloon Pre-dilatation: An Open Randomized Trial in Acute Myocardial Infarction safety and efficacy of the Genous Bio-engineered R Stent* pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent* pre-dilated with non drug eluting balloon in Patients undergoing PCI for ST-segment Elevation Myocardial Infarctio

Recruiting

Conditions: dilatation
Myocardial infarction
10011082

Registration Number: NL-OMON34545

Lead Sponsor: Diagram B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 128

Inclusion Criteria

Males or females >= 18 years of age and <= 80 years with symptoms of AMI of more than 30 minutes but less than 24 hours
ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more

Exclusion Criteria

Women of child-bearing potential
Severe hepatic or renal disease
Previous participation in the study
Life expectancy of < 1 year
Factors making follow-up difficult
AMI pre-treated with thrombolysis
Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA)
Known sensitivity to aspirin, clopidogrel, or coumadin
Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
Unable to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following outcome variables will be assessed:<br /><br>Late loss at 9 month angiography (primary endpoint)<br /><br><br /><br>Late loss is defined as the difference in millimeters between the Minimal Lumen<br /><br>Diameter (as measured by Quantitative Coronary Analysis) at the completion of<br /><br>the procedure and at angiographic follow-up. This is commonly used to measure<br /><br>the degree of intimal hyperplasia at follow-up. Late loss has the unique<br /><br>ability to distinguish the magnitude of late intimal renarrowing from baseline<br /><br>and procedural variables (reference vessel diameter and residual stenosis).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following outcome variables will be assessed:<br /><br>MACE at 30 day, 9 and 12 months (secondary endpoint)<br /><br>Procedure success<br /><br>Angiographic success (visual estimate)<br /><br>Device related SAEs until 12 months<br /><br>Angiographic stent thrombosis</p><br>