search
Back to results

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

Primary Purpose

Coronary Stenosis, Coronary Artery Disease

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Percutaneous coronary intervention (left main)
Sponsored by
University of Leipzig
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Stenosis focused on measuring left main coronary artery, coronary artery disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Significant left main coronary stenosis >= 50% Exclusion Criteria: Acute myocardial infarction (STEMI < 48h)

Sites / Locations

  • University of Leipzig, Heart CenterRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional status (CCS-class)

Full Information

First Posted
September 13, 2005
Last Updated
September 6, 2007
Sponsor
University of Leipzig
search

1. Study Identification

Unique Protocol Identification Number
NCT00176397
Brief Title
Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis
Official Title
PCI With DES Versus CABG for Patients With Significant Left Main Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis, Coronary Artery Disease
Keywords
left main coronary artery, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention (left main)
Primary Outcome Measure Information:
Title
Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)
Secondary Outcome Measure Information:
Title
Functional status (CCS-class)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Significant left main coronary stenosis >= 50% Exclusion Criteria: Acute myocardial infarction (STEMI < 48h)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enno Boudriot, MD
Phone
+49-341-865
Ext
1428
Email
boue@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Schuler, MD
Phone
+49-341-865
Ext
1428
Email
schug@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, MD
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Friedrich Mohr, MD
Organizational Affiliation
University of Leipzig
Official's Role
Study Director
Facility Information:
Facility Name
University of Leipzig, Heart Center
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enno Boudriot, MD
Phone
+49-341-865
Ext
1428
Email
boue@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Gerhard Schuler, MD
Phone
+49-341-865
Ext
1428
Email
schug@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Enno Boudriot, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs