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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Bx Sonic & Cypher stent from Cordis Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192881

Contact: Henning Kelbaek, MD
Contact: Lene Kloevgaard, RN

Rigshospitalet, Cardiac Cath Lab Recruiting
Copenhagen, Denmark, DK-2100
Contact: Henning Kelbaek, MD   
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark Identifier: NCT00192881     History of Changes
Other Study ID Numbers: SCANDSTENT A
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: July 2010

Keywords provided by Rigshospitalet, Denmark:
Percutaneous coronary intervention
Balloon angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases