Angioplasty of Left Main - lAriboisiere Registry

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Departement of Cardiology, Laribosiere Hospital, APHP

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Official study title

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

Acronym: ALMA

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2013
First posted: Nov 12, 2012
Registry last updated: Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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