Acute Myocardial Infarction PCI Drug eluting balloon stent
Conditions
Interventions
- Genous™ Bio-engineered R Stent™ + non-DEB
(non-drug eluting balloon)
- Genous™ Bio-engineered R Stent™ + DEB
(drug (Paclitaxel) eluting balloon (Dior™))
Sponsors
Maatschap Cardiologie Isala Klinieken
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females > 18 years of age and 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more
Exclusion criteria
Exclusion criteria: - Women of child-bearing potential 1. Severe hepatic or renal disease 2. Previous participation in the study 3. Life expectancy of 4.0 mm 5. Patients with lesions located in saphenous vein grafts 6. Patients with diffuse disease or poor flow distal to the target lesions 7. Patients with tortuous vessels in the region of the obstruction or proximal to the lesion 8. Patients treated with drug-eluting stents 9. Patients previously treated with drug-eluting balloon
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Late loss at 9 month follow-up by quantitative coronary angiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 1, 9 and 12 months after treatment. | — |
Contacts
Public ContactA. Kloosterman
DIAGRAM B.V.
Outcome results
None listed