We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University of Leipzig.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176397
First Posted: September 15, 2005
Last Update Posted: September 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Leipzig
  Purpose

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.


Condition Intervention Phase
Coronary Stenosis Coronary Artery Disease Procedure: Percutaneous coronary intervention (left main) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PCI With DES Versus CABG for Patients With Significant Left Main Stenosis

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)

Secondary Outcome Measures:
  • Functional status (CCS-class)

Estimated Enrollment: 200
Study Start Date: August 2003
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Significant left main coronary stenosis >= 50%

Exclusion Criteria:

  • Acute myocardial infarction (STEMI < 48h)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176397


Contacts
Contact: Enno Boudriot, MD +49-341-865 ext 1428 boue@medizin.uni-leipzig.de
Contact: Gerhard Schuler, MD +49-341-865 ext 1428 schug@medizin.uni-leipzig.de

Locations
Germany
University of Leipzig, Heart Center Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Enno Boudriot, MD    +49-341-865 ext 1428    boue@medizin.uni-leipzig.de   
Contact: Gerhard Schuler, MD    +49-341-865 ext 1428    schug@medizin.uni-leipzig.de   
Sub-Investigator: Enno Boudriot, MD         
Sponsors and Collaborators
University of Leipzig
Investigators
Study Director: Gerhard Schuler, MD University of Leipzig
Study Director: Friedrich Mohr, MD University of Leipzig
  More Information

ClinicalTrials.gov Identifier: NCT00176397     History of Changes
Other Study ID Numbers: 118/2003
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: September 10, 2007
Last Verified: September 2005

Keywords provided by University of Leipzig:
left main coronary artery
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Constriction, Pathologic
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical