Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192881
Recruitment Status : Unknown
Verified July 2010 by Rigshospitalet, Denmark.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2005
Last Update Posted : August 18, 2010
Information provided by:
Rigshospitalet, Denmark

September 12, 2005
September 19, 2005
August 18, 2010
October 2002
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Complete list of historical versions of study NCT00192881 on Archive Site
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Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
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
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: Bx Sonic & Cypher stent from Cordis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Rigshospitalet, Denmark
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Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark
Rigshospitalet, Denmark
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP