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Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

This study has been completed.
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: September 8, 2005
Last updated: September 12, 2005
Last verified: September 2005
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 Intervention
Ischaemic Heart Disease Device: Coronary Drug Eluting Stents for PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Minimal lumen diameter
  • Frequency of restenosis (>50%) at 6 months.

Secondary Outcome Measures:
  • Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months

Estimated Enrollment: 322
Study Start Date: October 2002
Estimated Study Completion Date: June 2006

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 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 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00151658

Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00151658     History of Changes
Other Study ID Numbers: SCANDSTENT
Study First Received: September 8, 2005
Last Updated: September 12, 2005

Keywords provided by Rigshospitalet, Denmark:
Coronary complex lesions
Drug eluting stents

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017