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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

NCT ID: NCT00176397

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Stenosis Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Percutaneous coronary intervention (left main)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Significant left main coronary stenosis \>= 50%

Exclusion Criteria

* Acute myocardial infarction (STEMI \< 48h)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Principal Investigators

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Gerhard Schuler, MD

Role: STUDY_DIRECTOR

University of Leipzig

Friedrich Mohr, MD

Role: STUDY_DIRECTOR

University of Leipzig

Locations

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University of Leipzig, Heart Center

Leipzig, Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Enno Boudriot, MD

Role: CONTACT

[email protected]
+49-341-865 ext. 1428

Gerhard Schuler, MD

Role: CONTACT

[email protected]
+49-341-865 ext. 1428

Facility Contacts

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Enno Boudriot, MD

Role: primary

[email protected]
+49-341-865 ext. 1428

Gerhard Schuler, MD

Role: backup

[email protected]
+49-341-865 ext. 1428

Other Identifiers

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118/2003

Identifier Type: -

Identifier Source: org_study_id