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

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00151658

Purpose

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.

Condition	Intervention
Ischaemic Heart Disease	Device: Coronary Drug Eluting Stents for PCI

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Multicenter Comparison of Sirolimus Versus Bare Metal Stent Implantation in Complex Coronary Lesions. Acronym: Scand Stent

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Sirolimus Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	322
Study Start Date:	October 2002
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151658

Locations

Denmark
Rigshospitalet
Copenhagen, Denmark, DK-2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Henning Kelbaek, MD

Rigshospitalet, Copenhagen, Denmark

More Information

No publications provided by Rigshospitalet, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kelbaek H, Kløvgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrøm T, Bøtker HE, Jørgensen E, Saunamäki K, Aljabbari S, Thayssen P, Galløe 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.

ClinicalTrials.gov Identifier:	NCT00151658 History of Changes
Other Study ID Numbers:	SCANDSTENT
Study First Received:	September 8, 2005
Last Updated:	September 12, 2005
Health Authority:	Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:

Coronary complex lesions
Restenosis
Drug eluting stents

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012