Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00151658
• Date of registration: 08/09/2005
• Prospective Registration: No
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)
• Scientific title: Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent
• Date of first enrolment: October 2002
• Target sample size: 322
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00151658
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Henning Kelbaek, MD
• Affiliation: Rigshospitalet, Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ischaemic Heart Disease

Intervention(s)

Device: Coronary Drug Eluting Stents for PCI

Primary Outcome(s)

Frequency of restenosis (>50%) at 6 months.

Minimal lumen diameter

Secondary Outcome(s)

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

Secondary ID(s)

SCANDSTENT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors