Sirolimus Eluting Stents in Complex Coronary Lesions (SCANDSTENT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

322 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Ischaemic Heart Disease

Keywords

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Coronary complex lesions Restenosis Drug eluting stents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Coronary Drug Eluting Stents for PCI

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Henning Kelbaek, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED

PMID: 18498953 (View on PubMed)

Other Identifiers

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SCANDSTENT

Identifier Type: -

Identifier Source: org_study_id