STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elutio

Completed

Conditions: Angina pectoris, myocardial infarction
Circulatory System
Angina

Registration Number: ISRCTN41213536

Lead Sponsor: Isala Clinics (Isala klinieken) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Men and women less than 85 years of age
2. Stable or unstable angina pectoris or a recent (less than 30 days) myocardial infarction with objective evidence of myocardial ischaemia
3. Lesion with more than 50% and less than 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

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 more than 20 mm in diameter
4. Left main coronary artery lesions
5. Ostial lesions
6. Left ventricular ejection fraction of less than 30%
7. Contraindication for follow-up angiography (severe peripheral vessel disease, creatine-clearance less than 30 ml/min)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean minimal lumen diameter at follow-up angiography.

Secondary Outcome Measures

Name	Time	Method
1. Clinical procedural success defined as angiographic success without major adverse cardiac events (MACE): death, myocardial infarction, or myocardial revascularisation by repeat angioplasty or coronary bypass surgery<br>2. Rate of major adverse clinical events during the nine and 24-month follow-up period