NCT00292305

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 angiographic follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

February 13, 2006

Last Update Submit

December 29, 2025

Conditions

Coronary Artery Disease

Keywords

PCIBifurcation lesion

Outcome Measures

Primary Outcomes (1)

  • Combined end point of: cardiac death, myocardial infarction, stent thrombosis or TVR

    after 6 months

Secondary Outcomes (12)

  • Clinical MACE

    December 2008

  • MACE (cardiac death, myocardial infarction, stent thrombosis or TVR)

    during hospital period; after 1 and 8 months

  • Cardiac death

    during hospital period; after 1, 6 and 8 months

  • Myocardial infarction

    during hospital period; after 1, 6 and 8 months

  • Stent thrombosis

    during hospital period; after 1, 6 and 8 months

  • +7 more secondary outcomes

Study Arms (2)

T-crush stenting

EXPERIMENTAL

Percutaneous coronary intervention with implantation of a stent

Procedure: Percutaneous coronary intervention

Culotte stenting

ACTIVE COMPARATOR

Percutaneous coronary intervention with stent

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE

Implantation of coronary stent in bifurcation lesions

Also known as: PCI, PTCA, Techniques, Crush, Culotte
Culotte stentingT-crush stenting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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".
  • Diameter of main vessel by visual estimate \> 3.0 mm.
  • Diameter of side branch by visual estimate \> 2.5 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.
  • Left main bifurcation in a non-right dominant system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skejby Hospital, University of Aarhus

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary InterventionMethodsNerve Crush

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative TechniquesDenervationNeurosurgical 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

February 13, 2006

First Posted

February 15, 2006

Study Start

September 1, 2005

Primary Completion

February 1, 2007

Study Completion

December 1, 2012

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(1)