Abdominal Aortic AneurysmNCT01783184
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 26 sites in France.
Trial summary
The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- How many people
- 180 participants
- Where
- 26 sitesFrance
- Study dates
- Jun 2012to Dec 2019
- 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: Abdominal Aortic Aneurysm (AAA)
Who may be able to join
- Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)
Who cannot join
- Patients for whom clinical follow-up is impossible and cannot return for check-up visits
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Clinique Casamance
Aubagne, 67091
Clinique Saint Etienne
Bayonne, 64100
Clinique Aguilera
Biarritz, 64200
Groupe Hospitalier Pellegrin
Bordeaux, 33000
Centre Hospitalier Jacques Coeur
Bourges, 18020
C.H. Prive Saint Martin
Caen, 14000
Infirmerie Protestante
Caluire-et-Cuire, 69300
Clinique Villette
Dunkirk, 59240
Centre Hospitalier Universitaire - Hopital Michallon
Grenoble, 38043
Clinique du Mail
La Rochelle, 17000
Centre Hospitalier
La Rochelle, 17019
Hopital Prive de l'Estuaire
Le Havre, 76620
Clinique de L'Yvette
Longjumeau, 91160
Clinique Bouchard
Marseille, 13006
Hopital Fondation Saint Joseph
Marseille, 13285
Hopital Prive Sainte Blandine
Metz, 57070
Centre Hospitalier
Moulins, 03006
Centre Hospitalalier Universitaire - Hopital Brabois
Nancy, 54000
Polyclinique Francheville
Périgueux, 24000
Centre Hospitalier
Périgueux, 24019
Centre Hospitalier de Roanne
Roanne, 42300
Clinique Saint Hilaire
Rouen, 76044
Clinique Guillaume de Varye
Saint-Doulchard, 18230
Clinique de l'Europe
Saint-Nazaire, 44600
Centre Hospitalier Universitaire - Hopital Civil
Strasbourg, 67091
Clinique Vauban
Valenciennes, 59300
About this study
Official title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
The Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.
Read the detailed description
Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route. This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients.
Abdominal aortic stent grafts, inserted via the femoral artery, are used to treat infrarenal abdominal aortic aneurysms, removing the need for an invasive surgical procedure.
The aim of this observational study is to evaluate the long-term (5 year) benefits of the technique by documenting the overall mortality, complications (endoleak, migration), rate of surgical conversion, progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use.
- Conditions
- Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality rate
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Mortality rate related to rupture of the aneurysm and relationship to the stent
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Change in diameter of the aneurysm
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of Type I, II and III endoleaks
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Surgical conversion rate
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of endovascular or surgical revisions
Measured: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2013
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Dominique Midy, Principal investigator, Groupe Hospitalier Pellegrin , Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783184
- Sponsor's protocol ID
- EPI-ANA01
- Status last verified
- Oct 2020
- First submitted
- 31 Jan 2013
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01783184
- Acronym / sponsor ID
- EPI-ANA01
- Conditions
- Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2012 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 4 Feb 2013 (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 Vascutek Anaconda™ Stent Graft System for repair of Abdominal Aortic Aneurysms (AAA) is the subject of this observational study. 180 patients will be implanted with the Anaconda™ Stent Graft System and will be followed-up annually for 5 years post-implant. The study will satisfy the requirements of the French National Authority for Health (Haute Autorité de santé) and the data collected will be used for reimbursement renewal.
Detailed description
Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route. This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients.
Abdominal aortic stent grafts, inserted via the femoral artery, are used to treat infrarenal abdominal aortic aneurysms, removing the need for an invasive surgical procedure.
The aim of this observational study is to evaluate the long-term (5 year) benefits of the technique by documenting the overall mortality, complications (endoleak, migration), rate of surgical conversion, progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abdominal Aortic Aneurysm (AAA)
Key inclusion criteria (1 listed)
- Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)
Key exclusion criteria (1 listed)
- Patients for whom clinical follow-up is impossible and cannot return for check-up visits
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
Overall mortality rate
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Mortality rate related to rupture of the aneurysm and relationship to the stent
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Change in diameter of the aneurysm
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of Type I, II and III endoleaks
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Surgical conversion rate
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of endovascular or surgical revisions
Time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 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 6 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Professor Dominique Midy principal investigator
Groupe Hospitalier Pellegrin , Bordeaux, France
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Vascutek Ltd. at 26 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 1 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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?
Overall mortality rate (time frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years). The study lists 6 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 6 Oct 2020.