NL-OMON34545
Recruiting
Not Applicable
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 Infarction - DEBORA2
Diagram B.V.0 sites128 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Diagram B.V.
- Enrollment
- 128
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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