Drug Eluting Balloon vs conventional balloon predilatation an Open Randomized trial in Acute myocardial infarction.
- Conditions
- Acute Myocardial InfarctionPCIDrug eluting balloonstent
- Registration Number
- NL-OMON27108
- Lead Sponsor
- Maatschap Cardiologie Isala Klinieken
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 68
Inclusion Criteria
1. Males or females > 18 years of age and < 80 years with symptoms of AMI of more than 30 minutes but less than 24 hours
2. 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
1. Severe hepatic or renal disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: <br /><br>- Late loss at 9 month follow-up by quantitative coronary angiography.
- Secondary Outcome Measures
Name Time Method Secondary endpoint: <br /><br>Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 1, 9 and 12 months after treatment.