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

June 11, 2026 updated by: Rennes University Hospital

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.

Study Overview

Status

Completed

Conditions

Interventional Cardiology

Study Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France
    - CHU Angers
  - Angers, France
    - Clinique Saint Joseph
  - Brest, France
    - CHU Brest
  - Caen, France
    - CHU Caen
  - Caen, France
    - Hôpital Prive Saint Martin
  - Chartres, France
    - CH Chartres
  - Laval, France
    - CH Laval
  - Le Mans, France
    - CH Le Mans
  - Lorient, France
    - CH Bretagne Sud
  - Nantes, France
    - Chu Nantes
  - Nantes, France
    - Nouvelles Cliniques Nantaises
  - Quimper, France
    - CH Intercommunal de Cornouaille
  - Rennes, France
    - CHU Rennes
  - Rennes, France
    - Hôpital privé Beauregard
  - Rennes, France
    - Polyclinique Saint-Laurent
  - Rouen, France
    - Chu Rouen
  - Rouen, France
    - Clinique Saint-Hilaire
  - Saint-Brieuc, France
    - CH Saint-Brieuc
  - Saint-Nazaire, France
    - CH Saint-Nazaire
  - Saint-Nazaire, France
    - Groupement Coopération Sanitaire Pui Cite Sanitaire
  - St-Malo, France
    - Communauté Hospitalière de Territoire Rance Emeraude
  - Toulon, France
    - Polyclinique Les Fleurs
  - Tours, France
    - CHU Tours
  - Tours, France
    - Clinique Saint Gatien
  - Vannes, France
    - CH Bretagne Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Intra-aortic Balloon Pumps 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
IABP insertion rate Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cardiogenic shock Time Frame: 1 year	IABP indications	1 year
Number of mechanical complication of acute coronary syndrome Time Frame: 1 year	IABP indications	1 year
Number of myocardial infarction not shocked Time Frame: 1 year	IABP indications	1 year
Number of other indications Time Frame: 1 year	IABP indications	1 year
Survival rate following IABP insertion Time Frame: 1 year		1 year
IABP-related complications rate and type Time Frame: 1 year		1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

Principal Investigator: Guillaume LEURENT, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimated)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

35RC14_8942

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.