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

NCT01496651 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1201

Last updated 2025-05-01

No results posted yet for this 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Evald Hoej Christiansen

    lead OTHER

Principal Investigators

  • Evald H Christiansen, MD · Aarhus University Hospital Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-06
Primary Completion
2015-01-22
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01496651 on ClinicalTrials.gov