NCT01496651Active, not recruiting
PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis
Nordic-Baltic-British Left Main Revascularization Study (NOBLE)
Source: ClinicalTrials.gov · Last updated 1 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1201 (actual)
- First submitted
- 19 Dec 2011
- Start date
- 6 Nov 2008
- Primary completion date
- 22 Jan 2015
- Lead sponsor
- Evald Hoej Christiansen
- Diseases
- Coronary artery disease
- NCT number
- NCT01496651
What you commit to
- Study type: Interventional
- Participants enrolled: 1201
- From 6 Nov 2008 to the primary completion date, 22 Jan 2015
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergy to aspirin, clopidogrel or ticlopidine.
- Allergy to Biolimus. \*\*Length \>25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion.
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Skejby | Denmark | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.