Xience® or Vision® stent - Management of Angina in the elderly

Completed

• Conditions: Coronary disease; acute coronary syndromes; Circulatory System; Other acute ischaemic heart diseases

• Registration Number: ISRCTN92243650
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined primary outcome at 1 year<br>1.1. Death<br>1.2. Myocardial infarction<br>1.3. Target Vessel Failure<br>1.4. Major haemorrhage<br>2. Procedural cost

Secondary Outcome Measures

Name	Time	Method
1. Angina status <br>2. Antianginal tablet prescription (Rx) <br>3. Procedural<br>3.1. Procedure success<br>3.2. Procedure Major Adverse Cardiac Events (MACE)<br>3.3. In-hospital complications<br>All secondary outcomes will be measured at 3, 6, 12 months.