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Clinical Trials in Denmark / NCT01496651
Active, not recruiting Not applicable

PCI vs. CABG in the Treatment of Unprotected Left Main Stenosis

NCT01496651 · tracked via the Priya Life Science Denmark tracker
Sponsor
Evald Hoej Christiansen
Phase
Not applicable
Started
2008-11-06
Last updated
2025-05-01

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Percutaneous coronary interventionCoronary artery bypass graft operation

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Aarhus University Hospital Skejby Aarhus N

More Evald Hoej Christiansen trials in Denmark

The Nordic-Baltic Bifurcation Study IV Active, not recruiting

Other trials for the same condition

VIsualization of Coronary Artery Disease for Modification of RISK Factors Active, not recruiting
The Nordic-Baltic Bifurcation Study IV Active, not recruiting
Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial Starting soon
Precise Procedural and PCI Plan (P4) Active, not recruiting
Personalized Evaluation of Susptected Myocardial Ischemia Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01496651 on ClinicalTrials.gov ↗ ← All trials in Denmark