Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00151658
First received: September 8, 2005
Last updated: September 12, 2005
Last verified: September 2005
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00151658

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

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00151658     History of Changes
Other Study ID Numbers: SCANDSTENT
Study First Received: September 8, 2005
Last Updated: September 12, 2005
Health Authority: Denmark: National Board of Health

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

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

ClinicalTrials.gov processed this record on October 22, 2014