Angioplasty of Left Main - lAriboisiere Registry

Coronary Artery Disease Clinical Trial

— ALMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725373
• Other study ID #: LRB-06-012
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: January 12, 2014
• Start date: January 2007
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Departement of Cardiology, Laribosiere Hospital, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major cardiovascular events (MACCE)	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.	One year	No