PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis (LeftMain/NOBLE)
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ClinicalTrials.gov Identifier: NCT01496651 |
Recruitment Status :
Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : January 6, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Procedure: Percutaneous coronary intervention Procedure: Coronary artery bypass graft operation | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1201 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Nordic-Baltic-British Left Main Revascularization Study (NOBLE) |
Actual Study Start Date : | November 6, 2008 |
Actual Primary Completion Date : | January 22, 2015 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
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Active Comparator: Percutaneous coronary intervention
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis
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Procedure: Percutaneous coronary intervention
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. Other Names:
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Active Comparator: Coronary artery bypass graft operation
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis
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Procedure: Coronary artery bypass graft operation
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.
Other Name: CABG |
- Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG) [ Time Frame: From date of first randomisation until a total number of 275 events is reached (or max 5 years). ]
- Combined endpoint of death, stroke and non-index treatment related MI [ Time Frame: 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 [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- All cause mortality [ Time Frame: 10 years ]
- New revascularization by CABG or PCI [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- Death [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- Definite stent thrombosis/symptomatic graft occlusion [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- CCS angina score [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- NYHA functional class [ Time Frame: 30 days, yearly through 5 years and when a total number of 275 events is reached. ]
- Duration of admission for index treatment [ Time Frame: Baseline ]
- Syntax score [ Time Frame: Baseline ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496651
Denmark | |
Aarhus University Hospital | |
Skejby, Aarhus N, Denmark, 8200 |
Principal Investigator: | Evald H Christiansen, MD | Aarhus University Hospital Skejby |
Responsible Party: | Evald Hoej Christiansen, MD, DMSc, Aarhus University Hospital Skejby |
ClinicalTrials.gov Identifier: | NCT01496651 |
Other Study ID Numbers: |
LeftMain/NOBLE |
First Posted: | December 21, 2011 Key Record Dates |
Last Update Posted: | January 6, 2021 |
Last Verified: | January 2021 |
Percutaneous coronary intervention Coronary artery bypass graft operation Left Main |
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |