Xience or Vision Stent Management of Angina in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug eluting stent

Percutaneous coronary intervention

Group Type OTHER

Percutaneous Coronary Intervention using drug eluting stents

Intervention Type PROCEDURE

Percutaneous Coronary Intervention using drug eluting stents

Bare Metal Stent

Percutaneous Coronary Intervention

Group Type OTHER

Percutaneous Coronary Intervention using bare metal stents

Intervention Type PROCEDURE

Percutaneous Coronary Intervention using bare metal stents

Interventions

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Percutaneous Coronary Intervention using drug eluting stents

Intervention Type PROCEDURE

Percutaneous Coronary Intervention using bare metal stents

Intervention Type PROCEDURE

Other Intervention Names

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Xience Drug eluting stent Vision BM stent

Eligibility Criteria

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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

Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No