Ruptured Aorta-iliac AneurysmsECARNCT00577616
Ruptured Aorta-iliac Aneurysms: Endo vs. Surgery
A study testing Endovascular repair in people with Ruptured Aorta-iliac Aneurysms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this multicenter randomized trial is to compare the endovascular repair versus conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients with suitable anatomy. The main awaited result is the significant reduction of the mortality of the conventional repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ruptured Aorta-iliac Aneurysms
- What is being tested?
- Endovascular repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Feb 2014
- 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
- Age >= 18 years
- Ruptured aorta-iliac aneurysms diagnosed by CT
- scan with injection.
- Aneurysm developed on native infra-renal aorta or iliac.
- Non infectious false aneurysms developed on prosthesis (Deleted by amendment n°1 at the request of AFSSAPS)
- Ruptured aneurysm after endoprosthesis (Deleted by amendment n°1 at the request of AFSSAPS)
Show all 9Show fewer
- Stable hemodynamic condition: systolic blood pressure on arrival higher than 80 mmHg in the absence of continuous vasopressive drugs administration.
- Anatomic criteria :length of aortic proximal neck >10 mm, diameter of aortic proximal neck < 32 mm, Absence of aortic neck angulation > 90° and patent iliac without important stenosis or tortuosity.
- Technical constraints (validation of experience form) : Trained operator (at least 15 endoprosthesis in asymptomatic patients), Endovascular materials at disposal
Who cannot join
- Unstable hemodynamic condition
- Anatomic criteria of non-inclusion
- Asymptomatic aneurysm
- Non-ruptured symptomatic aneurysm or aneurysm complicated with emboli.
- Mycotic aneurysm, infectious false aneurysms
- Post-traumatic aneurysm
Show all 10Show fewer
- Supra-renal thoracic-abdominal aneurysm
- Impossibility to obtain a CT-scan with injection
- Patient non-affiliated to the social security and the protected people
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study Comparing Endovascular Repair Versus Conventional Repair for Ruptured Aorta-iliac Aneurysms
The aim of this multicenter randomized trial is to compare the endovascular repair versus conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients with suitable anatomy. The main awaited result is the significant reduction of the mortality of the conventional repair.
Read the detailed description
The total death rate of ruptured aorta-iliac aneurysms is around 90%. A meta-analysis published by Bown et al. in 2002 in British Journal of Surgery finds on 171 studies compiled since 1955 an operational mortality post of the conventional surgery of 47%. This figure of post-operative mortality seems incompressible since many years in spite of the improvement of the techniques of anaesthesia and the surgery. The endovascular repair of the asymptomatic aneurysms of the abdominal aorta proved to be feasible and effective. In studies with limited and selected patients, the endovascular repair of ruptured aorta-iliac aneurysms seems to show a reduction in post-operative mortality in the average of 20%. However, the only comparative study (n=32) could not highlight of significant difference.This justifies a multicentric randomized study of which the goal is to compare the Endovascular repair and the Conventional repair in a cohort of a minimum of 160 patients carrying a Ruptured aorta-iliac Aneurysm(study name: ECAR) observed on CT-scan and being able to profit from the 2 techniques.The emergency does not allow the randomization by patient. The unit of randomization will be the week for each center, one week of endovascular treatment in alternation with one week of treatment by conventional repair and that in a synchronous way for the unit of all the centers of the study. The first week will be devoted to the conventional surgery and will be effective as of the opening of the first center. The principal objective is to compare mortality at 30 days in both groups. The secondary objectives are to compare in the 2 groups:• Morbidity (cardiac, pulmonary, renal, neurological, digestive) at 30 days.• Duration of stay in intensive care unit. The principal awaited results are a significant reduction in the mortality of the endovascular repair compared to the conventional surgery and a reduction in morbidity.
- Conditions
- Ruptured Aorta-iliac Aneurysms
- Being tested
- Endovascular repair
- Keywords
- Endovascular repair, Ruptured aorta-iliac aneurysms, Mortality at 30 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular repairProcedure or surgery
Endovascular repair of the asymptomatic aneurysms of the abdominal aorta
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Endovascular repair Receives: Procedure: Endovascular repair |
| 2 | Other | conventional surgery repair Receives: Procedure: Endovascular repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 30 days after the treatment(endovascular repair versus conventional repair)
Measured: 30 days after the treatment
Secondary outcomes (3)
Compare at 30 days after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity, other…- Duration of stay in intensive care unit- Quantity of blood transfusions
Measured: 30 days after the treatment
Compare at 6 month after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
Measured: 6 month after treatment
Compare at one year after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
Measured: one year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ruptured Aorta-iliac 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Desgranges, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577616
- Sponsor's protocol ID
- AOM06055
- Other IDs
- K060216
- Acronym
- ECAR
- Status last verified
- Jul 2013
- First submitted
- 19 Dec 2007
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alsac JM, Desgranges P, Kobeiter H, Becquemin JP. Emergency endovascular repair for ruptured abdominal aortic aneurysms: feasibility and comparison of early results with conventional open repair. Eur J Vasc Endovasc Surg. 2005 Dec;30(6):632-9. doi: 10.1016/j.ejvs.2005.06.010. Epub 2005 Aug 1.
PubMed 16061405Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin JP; ECAR Investigators. Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2015 Sep;50(3):303-10. doi: 10.1016/j.ejvs.2015.03.028. Epub 2015 May 20.
PubMed 26001320Desgranges P, Kobeiter H, Castier Y, Senechal M, Majewski M, Krimi A. The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update. J Vasc Surg. 2010 Jan;51(1):267-70. doi: 10.1016/j.jvs.2009.10.128.
PubMed 20117503
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Endovascular Repair Versus Conventional Repair for Ruptured Aorta-iliac Aneurysms
- ClinicalTrials.gov ID
- NCT00577616
- Acronym / sponsor ID
- ECAR / AOM06055
- Conditions
- Ruptured Aorta-iliac Aneurysms
- Keywords
- Endovascular repair, Ruptured aorta-iliac aneurysms, Mortality at 30 days
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Dec 2007 (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 multicenter randomized trial is to compare the endovascular repair versus conventional repair for ruptured aorta-iliac aneurysms observed on CT scan in stable patients with suitable anatomy. The main awaited result is the significant reduction of the mortality of the conventional repair.
Detailed description
The total death rate of ruptured aorta-iliac aneurysms is around 90%. A meta-analysis published by Bown et al. in 2002 in British Journal of Surgery finds on 171 studies compiled since 1955 an operational mortality post of the conventional surgery of 47%. This figure of post-operative mortality seems incompressible since many years in spite of the improvement of the techniques of anaesthesia and the surgery. The endovascular repair of the asymptomatic aneurysms of the abdominal aorta proved to be feasible and effective. In studies with limited and selected patients, the endovascular repair of ruptured aorta-iliac aneurysms seems to show a reduction in post-operative mortality in the average of 20%. However, the only comparative study (n=32) could not highlight of significant difference.This justifies a multicentric randomized study of which the goal is to compare the Endovascular repair and the Conventional repair in a cohort of a minimum of 160 patients carrying a Ruptured aorta-iliac Aneurysm(study name: ECAR) observed on CT-scan and being able to profit from the 2 techniques.The emergency does not allow the randomization by patient. The unit of randomization will be the week for each center, one week of endovascular treatment in alternation with one week of treatment by conventional repair and that in a synchronous way for the unit of all the centers of the study. The first week will be devoted to the conventional surgery and will be effective as of the opening of the first center. The principal objective is to compare mortality at 30 days in both groups. The secondary objectives are to compare in the 2 groups:• Morbidity (cardiac, pulmonary, renal, neurological, digestive) at 30 days.• Duration of stay in intensive care unit. The principal awaited results are a significant reduction in the mortality of the endovascular repair compared to the conventional surgery and a reduction in morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Endovascular repairEndovascular repair |
| 2 | Other | Procedure: Endovascular repairconventional surgery repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >= 18 years
- Ruptured aorta-iliac aneurysms diagnosed by CT
- scan with injection.
- Aneurysm developed on native infra-renal aorta or iliac.
- Stable hemodynamic condition: systolic blood pressure on arrival higher than 80 mmHg in the absence of continuous vasopressive drugs administration.
Key exclusion criteria (10 listed)
- Unstable hemodynamic condition
- Anatomic criteria of non-inclusion
- Asymptomatic aneurysm
- Non-ruptured symptomatic aneurysm or aneurysm complicated with emboli.
- Mycotic aneurysm, infectious false aneurysms
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 repairEndovascular repair of the asymptomatic aneurysms of the abdominal aorta | Procedure or surgery | 1, 2 |
Primary outcome
Mortality at 30 days after the treatment(endovascular repair versus conventional repair)
Time frame: 30 days after the treatment
3 secondary outcomes
Compare at 30 days after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity, other…- Duration of stay in intensive care unit- Quantity of blood transfusions
Time frame: 30 days after the treatment
Compare at 6 month after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
Time frame: 6 month after treatment
Compare at one year after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
Time frame: one year after the treatment
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 23 Oct 2014.
- Background: PubMed 16061405Alsac JM, Desgranges P, Kobeiter H, Becquemin JP. Emergency endovascular repair for ruptured abdominal aortic aneurysms: feasibility and comparison of early results with conventional open repair. Eur J Vasc Endovasc Surg. 2005 Dec;30(6):632-9. doi: 10.1016/j.ejvs.2005.06.010. Epub 2005 Aug 1.
- Derived from this study: PubMed 26001320Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin JP; ECAR Investigators. Editor's Choice - ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aorto-iliaques Rompus): A French Randomized Controlled Trial of Endovascular Versus Open Surgical Repair of Ruptured Aorto-iliac Aneurysms. Eur J Vasc Endovasc Surg. 2015 Sep;50(3):303-10. doi: 10.1016/j.ejvs.2015.03.028. Epub 2015 May 20.
- Derived from this study: PubMed 20117503Desgranges P, Kobeiter H, Castier Y, Senechal M, Majewski M, Krimi A. The Endovasculaire vs Chirurgie dans les Anevrysmes Rompus PROTOCOL trial update. J Vasc Surg. 2010 Jan;51(1):267-70. doi: 10.1016/j.jvs.2009.10.128.
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.
Pascal Desgranges, PUPH 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 repair in people with Ruptured Aorta-iliac 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 9 inclusion and 10 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 23 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?
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?
Mortality at 30 days after the treatment(endovascular repair versus conventional repair) (time frame: 30 days after the treatment). 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 NCT00577616, which also lists 3 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 23 Oct 2014; AzTrials last refreshed its copy on 29 Oct 2026.