Nordic Bifurcation Stent Technique Study - Full Text View

Sponsors and Collaborators:	Skejby Hospital Cordis, Blokken 39, DK-3460 Birkerød
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00292305

Purpose

This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting stents. This is 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: (crush stenting) Procedure: Percutaneous coronary intervention: (culotte stenting)	Phase IV

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Crush- or Culotte Stenting of Bifurcation Lesions Using Drug Eluting Stents? A Randomized Nordic Multicenter Study

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

Combined end point of: cardiac death, myocardial infarction, stent thrombosis or TVR [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical MACE [ Time Frame: December 2008 ] [ Designated as safety issue: Yes ]
MACE (cardiac death, myocardial infarction, stent thrombosis or TVR) [ Time Frame: during hospital period; after 1 and 8 months ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
TVR [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: No ]
Total death [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: Yes ]
TLR [ Time Frame: during hospital period; after 1, 6 and 8 months ] [ Designated as safety issue: No ]
CCS-angina score [ Time Frame: after 6 and 8 months ] [ Designated as safety issue: No ]
Late loss of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]
Percentual diameter stenosis of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]
Angiographic restenosis (> 50% diameter stenosis) rate of main vessel and side branch [ Time Frame: after 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2005
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: Percutaneous coronary intervention: (crush stenting) Implantation of coronary stent in bifurcation lesions
2: Active Comparator	Procedure: Percutaneous coronary intervention: (culotte stenting) Implantation of coronary stent in bifurcation lesions

Show Detailed Description

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".
Diameter of main vessel by visual estimate > 3.0 mm.
Diameter of side branch by visual estimate > 2.5 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.
Left main bifurcation in a non-right dominant system.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292305

Locations

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

Sponsors and Collaborators

Skejby Hospital

Cordis, Blokken 39, DK-3460 Birkerød

Investigators

Study Director:

Leif Thuesen, MD

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

More Information

No publications provided

Responsible Party:	Aarhus University Hospital, Skejby ( Department of Cardiology B )
Study ID Numbers:	20050116
Study First Received:	February 13, 2006
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00292305 History of Changes
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:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009