Skip to main content
Clinical Trials/NCT02900456
NCT02900456
Unknown
Not Applicable

The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

Rennes University Hospital25 sites in 1 country177 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interventional Cardiology
Sponsor
Rennes University Hospital
Enrollment
177
Locations
25
Primary Endpoint
IABP insertion rate
Last Updated
8 years ago

Overview

Brief Summary

Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
January 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males and females at least of 18 of age;
  • Undergoing IABP treatment ;
  • Subject, relatives or legal guardian signified their non-opposition to participate in the study

Exclusion Criteria

  • IABP insertion in immediate post-intervention period

Outcomes

Primary Outcomes

IABP insertion rate

Time Frame: 1 year

Secondary Outcomes

  • Number of cardiogenic shock(1 year)
  • Number of mechanical complication of acute coronary syndrome(1 year)
  • Number of myocardial infarction not shocked(1 year)
  • Number of other indications(1 year)
  • Survival rate following IABP insertion(1 year)
  • IABP-related complications rate and type(1 year)

Study Sites (25)

Loading locations...

Similar Trials