Angioplasty of Left Main - lAriboisiere Registry

NCT ID: NCT01725373

Last Updated: 2014-01-14

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

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-11-30

Brief Summary

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In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.

Detailed Description

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Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.

The aim of the study is to evaluate major cardiovascular events in a "real world" registry.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Angioplasty of left main

Patients with:

* stable or unstable angina and/or documented ischemia
* de novo ≥50% stenosis in the left main stem referred for angioplasty

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* stable or unstable angina and/or documented ischemia
* 50% de novo ULMD referred for angioplasty

Exclusion Criteria

* acute coronary syndrome with ST elevation,
* cardiogenic shock or out of hospital cardiac arrest
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Lariboisière

OTHER

Sponsor Role lead

Responsible Party

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Dr Jean-Guillaume DILLINGER

Principal investigator - Medical Doctor in the Departement of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Henry, MD-PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Departement of Cardiology, Laribosiere Hospital, APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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LRB-06-012

Identifier Type: -

Identifier Source: org_study_id

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