NCT01496651

Brief Summary

Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis. In a clinical, randomized, 5-year follow-up study to compare essential clinical outcome parameters in patients with unprotected left main (LMCA) disease, treated with coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) using drug eluting stents (DES). DES-PCI of unprotected LMCA disease is non-inferior to CABG concerning the 2-year rate of death, myocardial infarction, stroke or new revascularization and concerning the 5-year rate of death.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,201

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 6, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2015

Completed
10.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6.2 years

First QC Date

December 19, 2011

Last Update Submit

April 28, 2025

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary interventionCoronary artery bypass graft operationLeft Main

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG)

    From date of first randomisation until a total number of 275 events is reached (or max 5 years).

Secondary Outcomes (10)

  • Combined endpoint of death, stroke and non-index treatment related MI

    30 days, yearly through 5 years and when a total number of 275 events is reached.

  • Individual endpoints of death, stroke and non-index treatment related MI

    30 days, yearly through 5 years and when a total number of 275 events is reached.

  • All cause mortality

    10 years

  • New revascularization by CABG or PCI

    30 days, yearly through 5 years and when a total number of 275 events is reached.

  • Death

    30 days, yearly through 5 years and when a total number of 275 events is reached.

  • +5 more secondary outcomes

Study Arms (2)

Percutaneous coronary intervention

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis

Procedure: Percutaneous coronary intervention

Coronary artery bypass graft operation

ACTIVE COMPARATOR

Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis

Procedure: Coronary artery bypass graft operation

Interventions

Percutaneous coronary interventionPROCEDURE

PCI will be performed by the femoral or the transradial approach. In complex distal lesion anatomies, the use of 7-8F guiding catheters and the transfemoral approach may be recommended. Ostial and mid-shaft lesions will be treated with a single stent. For the treatment of distal bifurcation lesions crush, culotte, T-stenting, V-stenting or a single stent strategy may be used according the lesion morphology and the experience of the operator. However, based on the Nordic Bifurcation Studies the culotte technique seems to be associated with especially favorable angiographic and long-term clinical results in these large vessel size bifurcation lesions. There should be a low threshold for the use of high pressure post dilatation balloons. Generally, final kissing balloon dilatations are encouraged and mandatory when two-stent techniques are used. Intravascular ultrasound (IVUS) in mandatory pre and post stent placement.

Also known as: PCI, PTCA
Percutaneous coronary intervention
Coronary artery bypass graft operationPROCEDURE

Patients randomized to the CABG group for the treatment of LMCA stenosis are treated according to current clinical practice. Both off-pump and on-pump techniques can be used and the selection between the used methods is operator dependent. The left internal mammary artery will be used for the revascularization of the left anterior descending coronary artery, whenever feasible. For other lesion location, saphenous venous grafts, free arterial grafts or the right internal mammary artery may be used.

Also known as: CABG
Coronary artery bypass graft operation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable, unstable angina pectoris or ACS.
  • Significant lesion\* of LMCA ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex\*\* PCI lesions.
  • Patient eligible to be treated by CABG and by PCI
  • Signed informed consent. \*Visually assessed diameter stenosis \>50% or fractional flow reserve \<0.80. \*\*Length \<25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion.

You may not qualify if:

  • ST-elevation infarction within 24 hours.
  • CABG clearly better treatment option (LMCA stenosis and \>3, or complex\*\* additional coronary lesions)
  • Patient is in too high risk for CABG.
  • Expected survival \<1 year.
  • Allergy to aspirin, clopidogrel or ticlopidine.
  • Allergy to Biolimus. \*\*Length \>25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Skejby, Aarhus N, 8200, Denmark

Location

Related Publications (4)

  • Gaba P, Christiansen EH, Nielsen PH, Murphy SA, O'Gara PT, Smith PK, Serruys PW, Kappetein AP, Park SJ, Park DW, Stone GW, Sabik JF, Sabatine MS, Holm NR, Bergmark BA. Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft Surgery for Left Main Disease in Patients With and Without Acute Coronary Syndromes: A Pooled Analysis of 4 Randomized Clinical Trials. JAMA Cardiol. 2023 Jul 1;8(7):631-639. doi: 10.1001/jamacardio.2023.1177.

    PMID: 37256598DERIVED

  • Steigen T, Holm NR, Myrmel T, Endresen PC, Trovik T, Makikallio T, Lindsay M, Spence MS, Erglis A, Menown IBA, Kumsars I, Kellerth T, Davidavicius G, Linder R, Anttila V, Juul Hune Mogensen L, Hostrup Nielsen P, Graham ANJ, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE Study Investigators. Age-Stratified Outcome in Treatment of Left Main Coronary Artery Stenosis: A NOBLE Trial Substudy. Cardiology. 2021;146(4):409-418. doi: 10.1159/000515376. Epub 2021 Apr 13.

    PMID: 33849035DERIVED

  • Holm NR, Makikallio T, Lindsay MM, Spence MS, Erglis A, Menown IBA, Trovik T, Kellerth T, Kalinauskas G, Mogensen LJH, Nielsen PH, Niemela M, Lassen JF, Oldroyd K, Berg G, Stradins P, Walsh SJ, Graham ANJ, Endresen PC, Frobert O, Trivedi U, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial. Lancet. 2020 Jan 18;395(10219):191-199. doi: 10.1016/S0140-6736(19)32972-1. Epub 2019 Dec 23.

    PMID: 31879028DERIVED

  • Makikallio T, Holm NR, Lindsay M, Spence MS, Erglis A, Menown IB, Trovik T, Eskola M, Romppanen H, Kellerth T, Ravkilde J, Jensen LO, Kalinauskas G, Linder RB, Pentikainen M, Hervold A, Banning A, Zaman A, Cotton J, Eriksen E, Margus S, Sorensen HT, Nielsen PH, Niemela M, Kervinen K, Lassen JF, Maeng M, Oldroyd K, Berg G, Walsh SJ, Hanratty CG, Kumsars I, Stradins P, Steigen TK, Frobert O, Graham AN, Endresen PC, Corbascio M, Kajander O, Trivedi U, Hartikainen J, Anttila V, Hildick-Smith D, Thuesen L, Christiansen EH; NOBLE study investigators. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.

    PMID: 27810312DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Evald H Christiansen, MD

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

November 6, 2008

Primary Completion

January 22, 2015

Study Completion

December 31, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

DK(1)