Drug-Eluting Balloon vs Conventional Balloon Pre-dilatation: An Open Randomized Trial in Acute Myocardial Infarction.
- Conditions
- Acute myocardial infarction , Percutaneous Coronary Intervention (PCI), Drug eluting balloon, stent.
- Registration Number
- NL-OMON24399
- Lead Sponsor
- Isala Klinieken, Locatie Weezenlanden, Department of Cardiology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
1. Males or females 18 years of age or older and under 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
1. Women of child-bearing potential;
2. Severe hepatic or renal disease;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ate loss at 9 month follow-up by quantitative coronary angiography.
- Secondary Outcome Measures
Name Time Method Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 30 days, 9 and 12 months after treatment.