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Clinical Trials in Denmark / NCT01496638
Active, not recruiting Not applicable

The Nordic-Baltic Bifurcation Study IV

NCT01496638 · tracked via the Priya Life Science Denmark tracker
Sponsor
Evald Hoej Christiansen
Phase
Not applicable
Started
2008-12
Last updated
2026-01-02

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Implantation of coronary stent in bifurcation lesionImplantation of coronary stent in bifurcation lesion

Implantation of coronary stent in bifurcation lesion: Implantation of coronary stent in bifurcation lesion with no side branch treatment

Implantation of coronary stent in bifurcation lesion: Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch

Study 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 stenting the side branch if necessary.

The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac death, non-procedure related myocardial infarction and re-revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation — After 6 months

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Skejby Aarhus N

More Evald Hoej Christiansen trials in Denmark

PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis Active, not recruiting

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Precise Procedural and PCI Plan (P4) Active, not recruiting
Personalized Evaluation of Susptected Myocardial Ischemia Enrolling by invitation
Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01496638 on ClinicalTrials.gov ↗ ← All trials in Denmark