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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00176397
• Other study ID #: 118/2003
• Status: Recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 6, 2007
• Start date: August 2003

Study information

• Verified date: September 2005
• Source: University of Leipzig
• Contact: Enno Boudriot, MD
• Phone: +49-341-865
• Email: boue[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Significant left main coronary stenosis >= 50%

Exclusion Criteria:

• Acute myocardial infarction (STEMI < 48h)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention (left main)

Locations

Country	Name	City	State
Germany	University of Leipzig, Heart Center	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)
Secondary	Functional status (CCS-class)