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Clinical Trials/NCT00192881
NCT00192881
Unknown
Not Applicable

Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions

Rigshospitalet, Denmark1 site in 1 countryOctober 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Rigshospitalet, Denmark
Locations
1
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
TBD
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Stable, or unstable angina and/or objective signs of myocardial ischaemia
  • Informed consent
  • Optimal result (\< 35% residual stenosis and \< type C dissection) after balloon angioplasty
  • Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
  • Complex lesions to be included should have at least one of the following characteristics:
  • ostial in location (\< 5 mm from ostium)
  • total occlusions with a length ≥ 15 mm
  • bifurcational (side branch \> 1.75 mm in diameter)
  • angulated (\> 45° within lesion)
  • Exclusion criteria:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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