Acute myocardial infarction , Percutaneous Coronary Intervention (PCI), Drug eluting balloon, stent.
Conditions
Interventions
1. Genous™ Bio-engineered R Stent™ + non-DEB (non-drug eluting balloon)
2. Genous™ Bio-engineered R Stent™ + DEB
(drug (Paclitaxel) eluting balloon Pantera®)).
Sponsors
Isala Klinieken, Locatie Weezenlanden, Department of Cardiology
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Women of child-bearing potential; 2. Severe hepatic or renal disease; 3. Previous participation in the study; 4. Life expectancy of < 1 year; 5. Factors making follow-up difficult; 6. AMI pre-treated with thrombolysis; 7. Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA); 8. Known sensitivity to aspirin, clopidogrel, or coumadin; 9. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated; 10. Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late loss at 9 month follow-up by quantitative coronary angiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 30 days, 9 and 12 months after treatment. | — |
Contacts
Public ContactA. Kloosterman
DIAGRAM B.V.
Outcome results
None listed