Stable or unstable angina pectoris or a recent (<30 days) myocardial infarction with objective evidence of myocardial ischemia.
Conditions
Interventions
PCI:
Randomisation to Drug Eluted Stenting (DES) without (group Direct), with (group Conventional ) balloon predilatation or provisional stenting (group Provisional).
Sponsors
Dr AWJ van ¡¦t Hof
Isala Klinieken, locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
8011 JW Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and Women less than 85 years of age; 2. Stable or unstable angina pectoris or a recent ( 50% and < 100% diameter stenosis according to the estimate of the investigator; 4. Single American College of Cardiology/American Heart Association (ACC/AHA) task force classification type A, B1 or B2 non-calcified target lesion; 5. No contraindication to inhibition of platelet function with aspirin and ticlopidine or clopidogrel.
Exclusion criteria
Exclusion criteria: 1. Acute ST elevation myocardial infarction; 2. Unstable angina pectoris, classified as Braunwald category IIIB or C; 3. Bifurcation lesions situated with a side branch > 2.0 mm in diameter; 4. Left main coronary artery lesions; 5. Ostial lesions; 6. Left ventricular ejection fraction of <30%; 7. Contra-indication for follow-up angiography (severe peripheral vessel disease, creatine-clearance < 30 ml/min).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the mean minimal lumen diameter at follow-up angiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical procedural success defined as angiographic success without major adverse cardiac events (MACE): death, myocardial infarction, or myocardial revascularization by repeat angioplasty or coronary bypass surgery; 2. Rate of major adverse clinical events during the 9 and 24-month follow-up period. | — |
Contacts
Public ContactJ. Klijn
Diagram B.V. Zwolle Dokter Stolteweg 96
Outcome results
None listed