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
1 other identifier
interventional
322
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedSeptember 14, 2005
September 1, 2005
September 8, 2005
September 12, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Minimal lumen diameter
Frequency of restenosis (>50%) at 6 months.
Secondary Outcomes (1)
Diameter stenosis, late loss and loss index at 6 months MACE: death, myocardial infarction, target lesion revascularisation within 12 months and 24 months
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, DK-2100, Denmark
Related Publications (1)
Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe 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. doi: 10.1016/j.jacc.2008.01.056.
PMID: 18498953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henning Kelbaek, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
October 1, 2002
Study Completion
June 1, 2006
Last Updated
September 14, 2005
Record last verified: 2005-09