Interventional CardiologyCP-GARONCT02900456
The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
An observational study of Interventional Cardiology, run by Rennes University Hospital at 25 sites in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interventional Cardiology
- How many people
- 177 participants
- Where
- 25 sitesFrance
- Study dates
- Jan 2015to Jan 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- IABP insertion in immediate post-intervention period
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
CHU Angers
Angers
Clinique Saint Joseph
Angers
CHU Brest
Brest
CHU Caen
Caen
Hôpital Prive Saint Martin
Caen
CH Chartres
Chartres
CH Laval
Laval
CH Le Mans
Le Mans
CH Bretagne Sud
Lorient
CHU Nantes
Nantes
Nouvelles Cliniques Nantaises
Nantes
CH Intercommunal de Cornouaille
Quimper
CHU Rennes
Rennes
Hôpital privé Beauregard
Rennes
Polyclinique Saint-Laurent
Rennes
CHU Rouen
Rouen
Clinique Saint-Hilaire
Rouen
CH Saint-Brieuc
Saint-Brieuc
CH Saint-Nazaire
Saint-Nazaire
Groupement Coopération Sanitaire Pui Cite Sanitaire
Saint-Nazaire
Communauté Hospitalière de Territoire Rance Emeraude
St-Malo
Polyclinique Les Fleurs
Toulon
CHU Tours
Tours
Clinique Saint Gatien
Tours
CH Bretagne Atlantique
Vannes
About this study
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.
- Conditions
- Interventional Cardiology
- Keywords
- Intra-aortic Balloon Pumps, Registry
What is being measured
The primary outcome is the main question the study is designed to answer.
IABP insertion rate
Measured: 1 year
Secondary outcomes (6)
Number of cardiogenic shock
IABP indications
Measured: 1 year
Number of mechanical complication of acute coronary syndrome
IABP indications
Measured: 1 year
Number of myocardial infarction not shocked
IABP indications
Measured: 1 year
Number of other indications
IABP indications
Measured: 1 year
Survival rate following IABP insertion
Measured: 1 year
IABP-related complications rate and type
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional CardiologyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume LEURENT, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900456
- Sponsor's protocol ID
- 35RC14_8942
- Acronym
- CP-GARO
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
- ClinicalTrials.gov ID
- NCT02900456
- Acronym / sponsor ID
- CP-GARO / 35RC14_8942
- Conditions
- Interventional Cardiology
- Keywords
- Intra-aortic Balloon Pumps, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- IABP insertion in immediate post-intervention period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IABP insertion rate
Time frame: 1 year
6 secondary outcomes
Number of cardiogenic shock
Time frame: 1 year
Number of mechanical complication of acute coronary syndrome
Time frame: 1 year
Number of myocardial infarction not shocked
Time frame: 1 year
Number of other indications
Time frame: 1 year
Survival rate following IABP insertion
Time frame: 1 year
IABP-related complications rate and type
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LEURENT principal investigator
Rennes University Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interventional Cardiology, run by Rennes University Hospital at 25 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IABP insertion rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.