Percutaneous Coronary Intervention (PCI) With Drug-Elutin... | 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

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2007

Last Update Posted Date

Sep 10, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of LeipzigOTHER

Collaborators

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous coronary intervention (left main)	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)

Secondary Outcomes

Measure	Description	Time Frame
Functional status (CCS-class)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Significant left main coronary stenosis >= 50%

Exclusion Criteria:

Acute myocardial infarction (STEMI < 48h)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Enno Boudriot, MD	Contact	+49-341-865	1428	boue@medizin.uni-leipzig.de
Gerhard Schuler, MD	Contact	+49-341-865	1428	schug@medizin.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Gerhard Schuler, MD	University of Leipzig	Study Director
Friedrich Mohr, MD	University of Leipzig	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leipzig, Heart Center	Recruiting	Leipzig	Saxony	04289	Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

ID	Term
D023921	Coronary Stenosis
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Term
D062645	Percutaneous Coronary Intervention

Ancestor Terms

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures