Status:
COMPLETED
Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Ischaemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT00151658
Start Date
October 1 2002
End Date
June 1 2006
Last Update
September 14 2005
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, DK-2100