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Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis

PCI With DES Versus CABG for Patients With Significant Left Main Stenosis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00176397
Enrollment
200
Registered
2005-09-15
Start date
2003-08-31
Completion date
Unknown
Last updated
2007-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis

Keywords

left main coronary artery, coronary artery disease

Brief summary

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES). The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

Detailed description

Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES). The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis. The study was planned as a non-inferiority trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.

Interventions

PROCEDUREPercutaneous coronary intervention (left main)

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Significant left main coronary stenosis \>= 50%

Exclusion criteria

* Acute myocardial infarction (STEMI \< 48h)

Design outcomes

Primary

MeasureTime frame
Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)

Secondary

MeasureTime frame
Functional status (CCS-class)

Countries

Germany

Contacts

Primary ContactEnno Boudriot, MD
boue@medizin.uni-leipzig.de+49-341-865
Backup ContactGerhard Schuler, MD
schug@medizin.uni-leipzig.de+49-341-865

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026