Status:
COMPLETED
Nordic Bifurcation Stent Technique Study (BIF II)
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
Design: * Randomized open multicentre trial. Patients: * Number 400. Randomization: * Treatment strategy culotte technique or T-crush stenting Primary end-point: * Combined end point of: cardia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00292305
Start Date
September 1 2005
End Date
December 1 2012
Last Update
January 2 2026
Active Locations (1)
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1
Skejby Hospital, University of Aarhus
Aarhus, Denmark, 8200