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Clinical Trials/NCT00192881
NCT00192881UnknownNot 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, Denmark2 sites in 1 countryStarted: October 2002Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •Other severe disease with an expected survival < 1 year
  • •Other significant cardiac disease
  • •Known allergy against paclitaxel, clopidogrel (or ticlopidine),
  • •Myocardial infarction within 3 days of the index procedure
  • •Linguistic difficulties needing an interpreter
  • •Renal insufficiency (p-creatinine > 200 micromol/l)
  • •Gastrointestinal bleeding within 1 month
  • •Childbearing potential or pregnancy
  • •Participation in another study
  • •Unprotected left main disease
  • •Restenosis
  • •Lesions containing visible thrombus
  • •Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
  • •Diffuse coronary disease distal to the treated lesion
  • •Heavily calcification
  • •Lesion located in saphenous vein graft

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (2)

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