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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176397
First received: September 13, 2005
Last updated: September 6, 2007
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PCI With DES Versus CABG for Patients With Significant Left Main Stenosis

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Significant left main coronary stenosis >= 50%

Exclusion Criteria:

  • Acute myocardial infarction (STEMI < 48h)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00176397     History of Changes
Other Study ID Numbers: 118/2003
Study First Received: September 13, 2005
Last Updated: September 6, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on June 18, 2013