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Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
This study has been completed.
Study NCT00151658   Information provided by Rigshospitalet, Denmark
First Received: September 8, 2005   Last Updated: September 12, 2005   History of Changes

September 8, 2005
September 12, 2005
October 2002
 
  • Minimal lumen diameter
  • Frequency of restenosis (>50%) at 6 months.
Same as current
Complete list of historical versions of study NCT00151658 on ClinicalTrials.gov Archive Site
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
Same as current
 
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

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.

 
 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Ischaemic Heart Disease
Device: Coronary Drug Eluting Stents for PCI
 
Kelbaek H, Kløvgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrøm T, Bøtker HE, Jørgensen E, Saunamäki K, Aljabbari S, Thayssen P, Galløe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008 May 27;51(21):2011-6.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
322
June 2006
 

Inclusion Criteria:

Stable, or unstable angina and/or objective signs of myocardial ischaemia 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:

Patients:

  • Other severe disease with an expected survival < 1 year
  • Other significant cardiac disease
  • Known allergy against paclitaxel, clopidogrel or stainless steel.
  • 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

Lesions:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00151658
 
SCANDSTENT
Rigshospitalet, Denmark
 
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Copenhagen, Denmark
Rigshospitalet, Denmark
September 2005

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