ISRCTN92243650
Completed
Not Applicable
A multicentre randomised controlled trial of drug-eluting versus bare metal stents in the treatment of patients over 80 years of age with complex coronary artery disease
Brighton and Sussex University Hospitals NHS Trust (UK)0 sites800 target enrollmentMarch 17, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary disease
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust (UK)
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \> 80 years
- •2\. Stable angina or acute coronary syndrome
- •3\. Coronary narrowing suitable for stenting that is either \=15mm long and/or \=3mm diameter.
- •4\. Any lesion with high risk of restenosis eg chronic total occlusion (CTO), bifurcation, severe calcification
- •5\. Any left main stem lesion
Exclusion Criteria
- •1\. Acute ST\-Segment Elevation Myocardial Infarction (STEMI)
- •2\. Cardiogenic shock
- •3\. Platelet count \=50 x 109/mm^3
- •4\. Patient life expectancy \< 1 year
- •5\. Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
- •6\. Recent major gastrointestinal (GI) haemorrhage (within 3 months)
- •7\. Any previous cerebral bleeding episode
- •8\. Participation in another investigational drug or device study
- •9\. Patient unable to give consent
- •10\. Clinical decision precluding the use of DES
Outcomes
Primary Outcomes
Not specified
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