Status:
ACTIVE_NOT_RECRUITING
The Nordic-Baltic Bifurcation Study IV
Lead Sponsor:
Evald Hoej Christiansen
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
How should coronary artery stenoses with significant side branch be stented? A strategy of stenting both main vessel and side branch compared to a strategy of stenting the main vessel and only stenti...
Detailed Description
Design: * Randomised open multicentre trial. Patients: * Number 450. Randomisation: * No side branch treatment group or stenting of main vessel and side branch group. Evaluation of endpoints: *...
Eligibility Criteria
Inclusion
- Stable or unstable angina pectoris or silent angina pectoris.
- Genuine bifurcation lesion ( Medina type 1,1,1 or 1,0,1 or 0,1,1)
- 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 \>2.75 mm.
- Signed informed consent.
Exclusion
- ST-elevation infarction within 24 hours.
- Side branch lesion length \>15 mm.
- Expected survival \< 1 year.
- S-creatinine \>200 µmol/l.
- Allergy to Aspirin, Clopidogrel or Ticlopidine.
- Allergy to Sirolimus.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01496638
Start Date
December 1 2008
End Date
January 1 2026
Last Update
January 2 2026
Active Locations (1)
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1
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200