Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? - Full Text View

Sponsors and Collaborators:	Skejby Hospital Cordis, Blokken 39, DK-3460 Birkerød, Denmark
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00376571

Purpose

How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch. A randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.

Condition	Intervention	Phase
Coronary Artery Disease	Procedure: Percutaneous coronary intervention	Phase IV

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? A Strategy of Routine Stenting Both Main Vessel and Side Branch Versus a Strategy of Routine Main Vessel Stenting and Optional Treatment of Side Branch

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

Combined end-point of cardiac death, MI, stent thrombosis or TVR after 6 months.

Secondary Outcome Measures:

Clinical: MACE (cardiac death, MI, stent thrombosis or TVR) during hospital period, after 1 and 8 months. Cardiac death, myocardial infarction, stent thrombosis, TVR, total death, TLR during hospital period, after 1, 6 and 8 months. Myocardial infarction
Angiographic: Restenosis of the main vessel and/or occlusion of the side branch. Late loss of main vessel and side branch after 8 months. Angiographic restenosis (>50% diameter stenosis) rate of main vessel and side branch after 8 months.

Estimated Enrollment:	400
Study Start Date:	October 2004
Estimated Study Completion Date:	August 2006

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stable or unstable AP.
Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterolateral branch or LM/Cx/LAD in a right dominant system.
Diameter of main vessel by visual estimate > 2.5 mm.
Diameter of side branch by visual estimate > 2.0 mm.
Signed informed consent.

Exclusion Criteria:

ST-elevation AMI within 24 hours.
Expected survival < 1 year.
S-creatinine > 200 Umol/l.
Allergy to Aspirin, Clopidogrel or Ticlopidine.
Allergy to sirolimus/paclitaxel.
Left main bifurcation in a non-right dominant system.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376571

Locations

Denmark
Skejby Hospital, University of Aarhus
Aarhus, Denmark, 8200

Sponsors and Collaborators

Skejby Hospital

Cordis, Blokken 39, DK-3460 Birkerød, Denmark

Investigators

Study Director:

Leif Thuesen, MD

Director, Cardiac Cath. Lab., Skejby Hospital, University of Aarhus

More Information

Study ID Numbers:	20040136
Study First Received:	September 14, 2006
Last Updated:	September 14, 2006
ClinicalTrials.gov Identifier:	NCT00376571
Health Authority:	Denmark: National Board of Health

Keywords provided by Skejby Hospital:

PCI
Bifurcation lesion

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009