Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions?

NCT00376571 | Completed Phase 4 DMC

• 1 other identifier: 20040136
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

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 of side branch. A randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.

Conditions

Coronary Artery Disease

Keywords

PCI; Bifurcation lesion

Outcome Measures

Primary Outcomes (1)

• Combined end-point of cardiac death, MI, stent thrombosis or TVR.

  After 6 months

Secondary Outcomes (2)

• Clinical: MACE (cardiac death, MI, stent thrombosis or TVR) during hospital period, after 1 and 8 months. Cardiac death, myocardial infarction, stent thrombosis, TVR, total death, TLR during hospital period, after 1, 6 and 8 months. Myocardial infarction

  During hospital period, after 1, 6 and months.

• Angiographic: Restenosis of the main vessel and/or occlusion of the side branch. Late loss of main vessel and side branch after 8 months. Angiographic restenosis (>50% diameter stenosis) rate of main vessel and side branch after 8 months.

  After 8 months

Study Arms (2)

Stenting of main vessel and side branch

EXPERIMENTAL

Percutaneous coronary intervention

Procedure: Percutaneous coronary intervention

No side branch treatment

EXPERIMENTAL

Percutaneous coronary intervention

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

Comparing treatment of either "no side branch treatment" versus "stenting of main vessel and side branch treatment"

Also known as: PCI, PTCA

No side branch treatment; Stenting of main vessel and side branch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Skejby Hospital, University of Aarhus

Aarhus, 8200, Denmark

Location

Related Publications (3)

• Behan MW, Holm NR, de Belder AJ, Cockburn J, Erglis A, Curzen NP, Niemela M, Oldroyd KG, Kervinen K, Kumsars I, Gunnes P, Stables RH, Maeng M, Ravkilde J, Jensen JS, Christiansen EH, Cooter N, Steigen TK, Vikman S, Thuesen L, Lassen JF, Hildick-Smith D. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016 Jun 21;37(24):1923-8. doi: 10.1093/eurheartj/ehw170. Epub 2016 May 8.

  PMID: 27161619 DERIVED

• Kervinen K, Niemela M, Romppanen H, Erglis A, Kumsars I, Maeng M, Holm NR, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galloe A, Narbute I, Sondore D, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Helqvist S, Vikman S, Wiseth R, Aaroe J, Jokelainen J, Thuesen L; Nordic PCI Study Group. Clinical outcome after crush versus culotte stenting of coronary artery bifurcation lesions: the Nordic Stent Technique Study 36-month follow-up results. JACC Cardiovasc Interv. 2013 Nov;6(11):1160-5. doi: 10.1016/j.jcin.2013.06.009.

  PMID: 24262616 DERIVED

• Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011 Feb 1;4(1):57-64. doi: 10.1161/CIRCINTERVENTIONS.110.958512. Epub 2011 Jan 4.

  PMID: 21205942 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Leif Thuesen, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 15, 2006
• Study Start: October 1, 2004
• Primary Completion: June 1, 2005
• Study Completion: March 1, 2011
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

DK (1)