Xience or Vision Stent Management of Angina in the Elderly (XIMA)

Brighton and Sussex University Hospitals NHS Trust

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Procedure: Percutaneous Coronary Intervention using drug eluting stents

Procedure: Percutaneous Coronary Intervention using bare metal stents

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02198716

Version 2.0 20.06.2008

Details and patient eligibility

About

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 of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.

Enrollment

800 patients

Sex

All

Ages

80+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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