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Coronary Artery Bypass Grafting Vs Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis (LeftMain/NOBLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01496651
First received: December 19, 2011
Last updated: January 30, 2015
Last verified: January 2015
  Purpose

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 Intervention Phase
Coronary Artery Disease Procedure: Percutaneous coronary intervention Procedure: Coronary artery bypass graft operation Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nordic-Baltic-British Left Main Revascularization Study (NOBLE)

Resource links provided by NLM:


Further study details as provided by Evald Hoej Christiansen, Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Combined endpoint of death, stroke, non-index treatment related MI and new revascularization (PCI or CABG) [ Time Frame: After 2 years ]

Secondary Outcome Measures:
  • Combined endpoint of death, stroke and non-index treatment related MI [ Time Frame: After 1 month and 1, 2, 3, 4 and 5 years ]
  • Individual endpoints of death, stroke and non-index treatment related MI [ Time Frame: After 1 month and after 1, 2, 3, 4 and 5 years ]
  • New revascularization by CABG or PCI [ Time Frame: After 1, 2 ,3 ,4 and 5 years ]
  • Death [ Time Frame: After 10 years ]
  • Definite stent thrombosis/symptomatic graft occlusion [ Time Frame: Index to 5 years ]
  • CCS angina score [ Time Frame: Index to 5 years ]
  • NYHA functional class [ Time Frame: Index to 5 years ]
  • Duration of admission for index treatment [ Time Frame: Index and 1 month ]

Estimated Enrollment: 1200
Study Start Date: November 2008
Estimated Study Completion Date: December 2018
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous coronary intervention
Coronary Artery Bypass Grafting Versus Drug Eluting Stent Percutaneous Coronary Angioplasty in the Treatment of Unprotected Left Main Stenosis
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:
  • PCI
  • PTCA
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496651

Locations
Denmark
Aarhus University Hospital
Skejby, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Evald Hoej Christiansen
Investigators
Principal Investigator: Evald H Christiansen, MD Aarhus University Hospital Skejby
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evald Hoej Christiansen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01496651     History of Changes
Other Study ID Numbers: LeftMain/NOBLE
Study First Received: December 19, 2011
Last Updated: January 30, 2015

Keywords provided by Evald Hoej Christiansen, Aarhus University Hospital Skejby:
Percutaneous coronary intervention
Coronary artery bypass graft operation
Left Main

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 27, 2017