Status:
COMPLETED
Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions?
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Design: \* Randomized open multicentre trial. Patients: * Number 400. Inclusion criteria: * Stable or unstable AP. * Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterola...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT00376571
Start Date
October 1 2004
End Date
March 1 2011
Last Update
January 2 2026
Active Locations (1)
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1
Skejby Hospital, University of Aarhus
Aarhus, Denmark, 8200