AneurysmNCT01526811
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
An observational study of Aneurysm and Aortic Aneurysm, run by Medtronic Cardiovascular at 20 sites in France.
Trial summary
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal
- What is being tested?
- Endurant Stent graft
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 20 sitesFrance
- Study dates
- Mar 2012to 21 Dec 2018
- 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: Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment
Who may be able to join
- Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
- Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
- Patient not opposed to the collection and release of his/her personal information
- Intention of physician to implant electively the Endurant™ Stent Graft System
Who cannot join
- Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Centre Hospitalier d'Avignon
Avignon, 84902
CHU de Besancon, Hôpital Jean Minjoz
Besançon, 25030
Médipôle de Savoie
Challes-les-Eaux, 73190
Hôpital Privé Sainte Marie
Chalon-sur-Saône, 71100
Groupe Hospitalier Henri-Mondor
Créteil, 94010
Clinique Claude Bernard
Ermont, 95120
Clinique du Mousseau
Évry, 91035
Clinique de la Présentation
Fleury-les-Aubrais, 45404
CHU Limoges
Limoges, 87042
Hôpital Privé Jean Mermoz
Lyon, 69008
Hôpital Paul Desbief
Marseille, 13002
Hôpital Ambroise Paré
Marseille, 13006
Hôpital Saint Joseph
Marseille, 13008
Clinique du Millenaire
Montpellier, 34960
CHU Nice, Hôpital Saint-Roch
Nice, 06006
Polyclinique Quimper Sud
Quimper, 29000
Clinique Belledonne
Saint-Martin-d'Hères, 38400
CHl Toulon - La Seyne sur Mer
Toulon, 83056
Clinique Sarrus Teinturiers
Toulouse, 31300
Clinique Saint Joseph
Trélazé, 49800
About this study
Official title: Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.
Read the detailed description
Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.
In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.
- Conditions
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Being tested
- Endurant Stent graft
- Keywords
- Endurant, Stent Graft, Abdominal Aortic Aneurysm
- Medical subject headings
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurant Stent graftDevice
Also called EVAR
Endurant Stent graft implantation
| Study group | Role | What they receive |
|---|---|---|
| AAA patients | Subjects presenting with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment with Endurant™ Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional study Receives: Device: Endurant Stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: through 5 years
Aneurysm diameter's change
Measured: through 5 years
Stent graft endoleaks (type I, II and III)
Measured: through 5 years
Stent Graft migration
Measured: through 5 years
Conversion to open surgical repair
Measured: through 5 years
Surgical or endovascular secondary procedures
Measured: through 5 years
Aneurysm-related mortality
Measured: through 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMar 2012
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Becquemin, MD, PhD, Principal investigator, Groupe Hospitalier Henri-Mondor, Créteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526811
- Sponsor's protocol ID
- P#8888
- Status last verified
- Oct 2021
- First submitted
- 27 Jan 2012
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study on Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01526811
- Acronym / sponsor ID
- P#8888
- Conditions
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
- Keywords
- Endurant, Stent Graft, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 6 Feb 2012 (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.
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.
Detailed description
Data regarding the use under routine practice of abdominal aortic stent grafts in France are expected by the French National Authority for Health (HAS). Therefore, in its opinion report from July 13, 2010, HAS makes the maintenance of reimbursement approval of each stent graft dependent on the presentation of results of a specific follow-up study carried out in a cohort of patients representative of the French population treated under real-life conditions of use. This prospective cohort study must involve at least 150 patients implanted after registration on the LPPR (List of Products and Services qualifying for Reimbursement). The results of the follow-up study must be forwarded to the National Committee for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) for examination once a year. The assessment of this follow-up could lead to the recommendation by CNEDiMTS to continue or stop the reimbursement of the concerned stent graft.
In France, The Endurant™ Stent Graft System is registered on the LPPR for a period of 3 years since September 13, 2011. In order to comply with HAS expectations, Medtronic Bakken Research Center is setting up this long term non-interventional study on the Endurant stent graft.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AAA patients | – | Device: Endurant Stent graftSubjects presenting with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment with Endurant™ Stent Graft, and who meet the inclusion/exclusion criteria are intended to participate in this non-interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with a non-ruptured infra-renal abdominal aortic aneurysm (AAA) and requiring endovascular treatment
Key inclusion criteria (4 listed)
- Patient with age ≥18 years, who is able to understand the information given by the investigator regarding the collection and release of his/her personal information and who is able to oppose to this collection and release.
- Any patient requiring placement of an abdominal aortic stent graft for the treatment of a non-ruptured infra-renal abdominal aortic aneurysm.
- Patient not opposed to the collection and release of his/her personal information
- Intention of physician to implant electively the Endurant™ Stent Graft System
Key exclusion criteria (1 listed)
- Patient in whom clinical follow-up will not be possible i.e. patient not able to come back for follow-up visits (ex. patient living abroad)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endurant Stent graftAlso: EVAREndurant Stent graft implantation | Device | AAA patients |
Primary outcome
All-cause mortality
Time frame: through 5 years
Aneurysm diameter's change
Time frame: through 5 years
Stent graft endoleaks (type I, II and III)
Time frame: through 5 years
Stent Graft migration
Time frame: through 5 years
Conversion to open surgical repair
Time frame: through 5 years
Surgical or endovascular secondary procedures
Time frame: through 5 years
Aneurysm-related mortality
Time frame: through 5 years
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 2 Nov 2021.
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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.
Jean-Pierre Becquemin, MD, PhD principal investigator
Groupe Hospitalier Henri-Mondor, Créteil, France
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Aortic Aneurysm, run by Medtronic Cardiovascular at 20 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 4 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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?
All-cause mortality (time frame: through 5 years). The study lists 7 primary outcomes in all. 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 2 Nov 2021.