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Clinical Trials/ISRCTN92243650
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.

Registry
who.int
Start Date
March 17, 2010
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Brighton and Sussex University Hospitals NHS Trust (UK)

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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