Aortic AneurysmsWindows1NCT01168037
Medical & Economical Evaluation of Fenestrated & Branched Stent-grafts to Treat Complex Aortic Aneurysms
An observational study of Aortic Aneurysms, 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 pararenal, supra-renal and type 4 THORACO-abdominal aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysms
- What is being tested?
- Endovascular aortic repair with branched/fenestrated stent-graft and Open Surgical Repair
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2009to 9 Feb 2015
- 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: All patients with an Abdominal aortic aneurysm over 5 cm in diameter or with a diameter increase over 1 cm in 1 year and a PSRAA defined by: * Infrarenal aortic neck < 15 mm * or extent of the aneurismal process to the suprarenal aorta
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 and Economical Evaluation of Endovascular Therapy of Complex Aortic Aneurysms (Para- & Supra- Renal Abdominal Aortic Aneurysms, Type 4 THORACO-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 pararenal, supra-renal and type 4 THORACO-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 (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).
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 pararenal, supra-renal and type 4 THORACO-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 (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, 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 Aneurysms
- Being tested
- Endovascular aortic repair with branched/fenestrated stent-graft, 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 repair with branched/fenestrated stent-graftDevice
Also called Endovascular aortic repair
Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
Open Surgical RepairProcedure or surgery
aortic replacement with revascularization of visceral arteries
| Study group | Role | What they receive |
|---|---|---|
| Open repair | Open Surgical Repair (aortic replacement with revascularization of visceral arteries) Receives: Procedure: Open Surgical Repair | |
| Endovascular (Windows 1) | Endovascular therapy branched or fenestrated stent-graft Receives: Device: Endovascular aortic repair with branched/fenestrated stent-graft | |
| Endovascular (Windows 3) | Endovascular therapy branched or fenestrated stent-graft (vascutek anaconda) Receives: Device: Endovascular aortic repair with branched/fenestrated stent-graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative mortality
Measured: 30-day postoperative
Secondary outcomes (8)
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
Mortality in touch with aneurysm
Measured: 2-year follow up
Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )
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 posted22 Jul 2010 (estimated)
- Study start17 Jun 2009
- Primary completion9 Feb 2015
- Study completion9 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 270 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
- NCT01168037
- Sponsor's protocol ID
- IC090126
- Acronym
- Windows1
- Status last verified
- Oct 2017
- First submitted
- 21 Jul 2010
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. doi: 10.1016/j.ejvs.2006.01.015. Epub 2006 Mar 31.
PubMed 16580236Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19.
PubMed 26100447Marzelle J, Presles E, Becquemin JP; WINDOWS trial participants. Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. Ann Surg. 2015 Jan;261(1):197-206. doi: 10.1097/SLA.0000000000000612.
PubMed 24670864Banno H, Kobeiter H, Brossier J, Marzelle J, Presles E, Becquemin JP. Inter-observer variability in sizing fenestrated and/or branched aortic stent-grafts. Eur J Vasc Endovasc Surg. 2014 Jan;47(1):45-52. doi: 10.1016/j.ejvs.2013.10.008. Epub 2013 Oct 23.
PubMed 24268517
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Economical Evaluation of Endovascular Therapy of Complex Aortic Aneurysms (Para- & Supra- Renal Abdominal Aortic Aneurysms, Type 4 THORACO-Abdominal Aneurysms) by Fenestrated & Branched Stent-grafts
- ClinicalTrials.gov ID
- NCT01168037
- Acronym / sponsor ID
- Windows1 / IC090126
- Conditions
- Aortic Aneurysms
- Keywords
- Aorta, Aneurysm, endovascular, stent-graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jun 2009 (actual)
- Primary completion
- 9 Feb 2015 (actual)
- Study completion
- 9 Feb 2015 (actual)
- First posted
- 22 Jul 2010 (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 pararenal, supra-renal and type 4 THORACO-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 (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).
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 pararenal, supra-renal and type 4 THORACO-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 (250 patients (amendment) treated in 8 University hospitals with significant experience of the technique) and open repair (660 similar patients analyzed form the national database of the MOH).
In-hospital morbidity are similarly expected to be lower in the endovascular group. We also wish to demonstrate that endovascular repair does not represent a significant over-cost, 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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open repair | – | Procedure: Open Surgical RepairOpen Surgical Repair (aortic replacement with revascularization of visceral arteries) |
| Endovascular (Windows 1) | – | Device: Endovascular aortic repair with branched/fenestrated stent-graftEndovascular therapy branched or fenestrated stent-graft |
| Endovascular (Windows 3) | – | Device: Endovascular aortic repair with branched/fenestrated stent-graftEndovascular therapy branched or fenestrated stent-graft (vascutek anaconda) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with an Abdominal aortic aneurysm over 5 cm in diameter or with a diameter increase over 1 cm in 1 year and a PSRAA defined by: * Infrarenal aortic neck < 15 mm * or extent of the aneurismal process to the suprarenal aorta
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 repair with branched/fenestrated stent-graftAlso: Endovascular aortic repairInsertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram | Device | Endovascular (Windows 1), Endovascular (Windows 3) |
| Open Surgical Repairaortic replacement with revascularization of visceral arteries | Procedure or surgery | Open repair |
Primary outcome
30-day postoperative mortality
Time frame: 30-day postoperative
8 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
Mortality in touch with aneurysm
Time frame: 2-year follow up
Annual cost (1 month, 6 month, 1 year and 2 year Follow-up screening )
Time frame: 2-year follow up
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 19 Oct 2017.
- Background: PubMed 16580236O'Neill S, Greenberg RK, Haddad F, Resch T, Sereika J, Katz E. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. doi: 10.1016/j.ejvs.2006.01.015. Epub 2006 Mar 31.
- Derived from this study: PubMed 26100447Michel M, Becquemin JP, Clement MC, Marzelle J, Quelen C, Durand-Zaleski I; WINDOW Trial Participants. Editor's choice - thirty day outcomes and costs of fenestrated and branched stent grafts versus open repair for complex aortic aneurysms. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):189-96. doi: 10.1016/j.ejvs.2015.04.012. Epub 2015 Jun 19.
- Derived from this study: PubMed 24670864Marzelle J, Presles E, Becquemin JP; WINDOWS trial participants. Results and factors affecting early outcome of fenestrated and/or branched stent grafts for aortic aneurysms: a multicenter prospective study. Ann Surg. 2015 Jan;261(1):197-206. doi: 10.1097/SLA.0000000000000612.
- Derived from this study: PubMed 24268517Banno H, Kobeiter H, Brossier J, Marzelle J, Presles E, Becquemin JP. Inter-observer variability in sizing fenestrated and/or branched aortic stent-grafts. Eur J Vasc Endovasc Surg. 2014 Jan;47(1):45-52. doi: 10.1016/j.ejvs.2013.10.008. Epub 2013 Oct 23.
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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?
An observational study of Aortic Aneurysms, 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: finished, as of the sponsor's last update on 19 Oct 2017. 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?
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?
30-day postoperative 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 NCT01168037, which also lists 4 linked publications.
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 19 Oct 2017.