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Clinical Trials/NCT01725373
NCT01725373
Completed
Not Applicable

Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry

Hopital Lariboisière1 site in 1 country125 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Hopital Lariboisière
Enrollment
125
Locations
1
Primary Endpoint
Major cardiovascular events (MACCE)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hopital Lariboisière
Responsible Party
Principal Investigator
Principal Investigator

Dr Jean-Guillaume DILLINGER

Principal investigator - Medical Doctor in the Departement of Cardiology

Hopital Lariboisière

Eligibility Criteria

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

Outcomes

Primary Outcomes

Major cardiovascular events (MACCE)

Time Frame: One year

Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.

Study Sites (1)

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