NCT01725373

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

5.3 years

First QC Date

November 8, 2012

Last Update Submit

January 12, 2014

Conditions

Coronary Artery Disease

Keywords

left main, stent,angioplasty

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with stenosis of unprotected left main and schedulded angioplasty in the Department of Cardiology, Lariboisiere Hospital.

You may qualify if:

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

You may not qualify if:

  • acute coronary syndrome with ST elevation,
  • cardiogenic shock or out of hospital cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Cardiology, Laribosiere Hospital, APHP

Paris, 75010, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Patrick Henry, MD-PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator - Medical Doctor in the Departement of Cardiology

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 12, 2012

Study Start

January 1, 2007

Primary Completion

May 1, 2012

Study Completion

November 1, 2013

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FR(1)