Status:
COMPLETED
Xience or Vision Stent Management of Angina in the Elderly
Lead Sponsor:
Brighton and Sussex University Hospitals NHS Trust
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
80+ years
Phase:
NA
Brief Summary
The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint...
Eligibility Criteria
Inclusion
- AGE\>80
- Stable angina or acute coronary syndrome
- Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
- Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
- Any left main stem lesion
Exclusion
- Acute ST segment elevation myocardial infarction
- Cardiogenic shock
- Platelet count =50 x 109/mm3
- Patient life expectancy \< 1 year
- Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
- Recent major GI haemorrhage (within 3 months)
- Any previous cerebral bleeding episode
- Participation in another investigational drug or device study
- Patient unable to give consent
- Clinical decision precluding the use of drug eluting stent
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT02198716
Start Date
November 1 2008
End Date
August 1 2012
Last Update
August 15 2014
Active Locations (1)
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1
Cardiac Research Unit
Brighton, Sussex, United Kingdom, BN2 1ES