Aortic AneurysmWindows2NCT01354821
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Thoracal Abdominal Aneurysms
A study testing Endovascular aortic repair and Open surgical repair in people with Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Endovascular aortic repair and Open surgical repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- The following anatomical inclusion criteria must be met:
- Absence of significant angulations (< 60°) of aorta or of iliac arteries
- Absence of tight stenosis (>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
- Diameter of target arteries over 5 mm
- Iliac and femoral arteries allowing insertion of the delivery system (> 7 mm) or suitable for insertion of an access conduit
Who cannot join
- Limited expected life expectancy
- Emergency cases
- Refuse to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.
Read the detailed description
The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.
The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. The investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.
- Conditions
- Aortic Aneurysm
- Being tested
- Endovascular aortic repair, Open surgical repair
- Keywords
- Aorta, Aneurysm, endovascular, stent-graft
- Medical subject headings
- Aortic Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular aortic repairProcedure or surgery
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
Open surgical repairProcedure or surgery
Conventional therapy in France with the national database of the M.O.H.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy branched | Active comparator | Endovascular therapy branched or fenestrated stent-graft Receives: Procedure: Endovascular aortic repair |
| Open surgical repair | Other | Open surgical repair or aortic replacement with revascularization of visceral arteries Receives: Procedure: Open surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30-day postoperative
Secondary outcomes (6)
complications
Measured: 30-day postoperative
Length of Intensive Care Unit (ICU) stay
Measured: 30-day postoperative
Length of Hospital stay
Measured: 30-day postoperative
Overall cost
Measured: 30-day postoperative
Reinterventions
Measured: 2-year follow up
Global survival
Measured: 2-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Becquemin, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354821
- Sponsor's protocol ID
- P090209
- Acronym
- Windows2
- Status last verified
- Oct 2014
- First submitted
- 16 May 2011
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Recherche en Chirurgie Vasculaire. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-44. doi: 10.1016/j.ejvs.2009.12.008. Epub 2010 Jan 25.
PubMed 20093051
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical & Economical Evaluation of Endovascular Therapy of Complex Thoracal Abdominal Aneurysms (Type 1-3 Thoracal Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
- ClinicalTrials.gov ID
- NCT01354821
- Acronym / sponsor ID
- Windows2 / P090209
- Conditions
- Aortic Aneurysm
- Keywords
- Aorta, Aneurysm, endovascular, stent-graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 May 2011 (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 aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.
Detailed description
The aim of this study is to prospectively compare the perioperative mortality severe morbidity and the costs of endovascular versus conventional surgical repair of type 1, 2 and 3 thoracal abdominal aortic aneurysms.
The primary goal of the study is to demonstrate a significant drop in 30-day mortality and life threatening morbidity in the endovascular arm of the study. Our hypothesis, derived from the literature, that the average 30-days mortality is 3% after endovascular repair and 10% after open surgery justifies the design of a prospective study between endovascular therapy (50 patients (amendment n.5 - 9/07/2013) treated in 5 University hospitals with significant experience of the technique) and open repair (220 similar patients analyzed from the national database of the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. The investigators also wish to demonstrate that endovascular repair does not represent a significant overcost, as compared to open repair. The cost of the implantable medical device (IMD), of follow-up screening, and of eventual repeated interventions should be compensated by a reduced stay in intensive care unit ICU, and by a reduced in-hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy branched | Active comparator | Procedure: Endovascular aortic repairEndovascular therapy branched or fenestrated stent-graft |
| Open surgical repair | Other | Procedure: Open surgical repairOpen surgical repair or aortic replacement with revascularization of visceral arteries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Absence of significant angulations (< 60°) of aorta or of iliac arteries
- Absence of tight stenosis (>70%) of more than one target artery (renal or visceral artery to be perfused from the side holes of the stent-graft)
- Diameter of target arteries over 5 mm
- Iliac and femoral arteries allowing insertion of the delivery system (> 7 mm) or suitable for insertion of an access conduit
Key exclusion criteria (3 listed)
- Limited expected life expectancy
- Emergency cases
- Refuse to participate to the study
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 |
|---|---|---|
| Endovascular aortic repairInsertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram | Procedure or surgery | Endovascular therapy branched |
| Open surgical repairConventional therapy in France with the national database of the M.O.H. | Procedure or surgery | Open surgical repair |
Primary outcome
mortality
Time frame: 30-day postoperative
6 secondary outcomes
complications
Time frame: 30-day postoperative
Length of Intensive Care Unit (ICU) stay
Time frame: 30-day postoperative
Length of Hospital stay
Time frame: 30-day postoperative
Overall cost
Time frame: 30-day postoperative
Reinterventions
Time frame: 2-year follow up
Global survival
Time frame: 2-year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Background: PubMed 20093051Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P, Goueffic Y, Jean-Baptiste E, Cochennec F, Favre JP; Association Universitaire de Recherche en Chirurgie Vasculaire. Fenestrated endovascular grafting: the French multicentre experience. Eur J Vasc Endovasc Surg. 2010 May;39(5):537-44. doi: 10.1016/j.ejvs.2009.12.008. Epub 2010 Jan 25.
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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, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular aortic repair and Open surgical repair in people with Aortic Aneurysm, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
mortality (time frame: 30-day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354821, which also lists 1 linked publication.
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 30 Oct 2014.