NCT00176397

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 6, 2007

Conditions

Coronary StenosisCoronary Artery Disease

Keywords

left main coronary arterycoronary artery disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Functional status (CCS-class)

Interventions

Percutaneous coronary intervention (left main)PROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant left main coronary stenosis \>= 50%

You may not qualify if:

  • Acute myocardial infarction (STEMI \< 48h)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig, Heart Center

Leipzig, Saxony, 04289, Germany

RECRUITING

MeSH Terms

Conditions

Coronary StenosisCoronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Gerhard Schuler, MD

    University of Leipzig

    STUDY DIRECTOR

  • Friedrich Mohr, MD

    University of Leipzig

    STUDY DIRECTOR

Central Study Contacts

Enno Boudriot, MD

CONTACT

+49-341-865boue@medizin.uni-leipzig.de

Gerhard Schuler, MD

CONTACT

+49-341-865schug@medizin.uni-leipzig.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2003

Last Updated

September 10, 2007

Record last verified: 2005-09

Locations

DE(1)