Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT) - Tabular View

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Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

This study has been completed.

Study NCT00151658. Last updated on September 12, 2005. Information provided by Rigshospitalet, Denmark

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Official Title ^†

Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Ischaemic Heart Disease

Intervention ^†

Device: Coronary Drug Eluting Stents for PCI

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

322

Start Date ^†

October 2002

Completion Date

June 2006

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Administrative Information Fields

NCT ID ^†

NCT00151658

Organization ID

SCANDSTENT

Secondary IDs ^††

Study Sponsor ^†

Rigshospitalet, Denmark

Collaborators ^††

Investigators ^†

Principal Investigator:

Henning Kelbaek, MD

Rigshospitalet, Copenhagen, Denmark

Information Provided By

Rigshospitalet, Denmark

Verification Date

September 2005

First Received Date ^†

September 8, 2005

Last Updated Date

September 12, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.