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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT00577616 |
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Date of registration:
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19/12/2007 |
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Primary sponsor: |
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Public title:
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Ruptured Aorta-iliac Aneurysms: Endo vs. Surgery
ECAR |
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Scientific title:
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Randomized Study Comparing Endovascular Repair Versus Conventional Repair for Ruptured Aorta-iliac Aneurysms |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00577616 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Pascal Desgranges, PUPH |
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Address:
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Telephone:
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01 49 81 24 05 |
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Email:
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pascal.desgranges@hmn.aphp.fr |
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Affiliation:
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Name:
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Pascal Desgranges, PU-PH |
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Address:
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Telephone:
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(0) 1 49 81 24 05 |
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Email:
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pascal.desgranges@hmn.aphp.fr |
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Affiliation:
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Name:
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Pascal Desgranges, PUPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ruptured Aorta-iliac Aneurysms
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Intervention(s)
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Procedure: Endovascular repair
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Primary Outcome(s)
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Mortality at 30 days after the treatment(endovascular repair versus conventional repair)
[Time Frame: 30 days after the treatment]
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Secondary Outcome(s)
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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]
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Compare at 6 month after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
[Time Frame: 6 month after treatment]
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Compare at one year after the treatment the:- Cardiac , pulmonary, digestive , renal neurological morbidity (amendment 6)
[Time Frame: one year after the treatment]
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Secondary ID(s)
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AOM06055
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K060216
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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