Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
NCT ID: NCT00235118
Last Updated: 2005-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
29 participants
INTERVENTIONAL
1999-12-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Cordis AAA Bilateral Device
Eligibility Criteria
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Inclusion Criteria
Aortic Aneurysm Diameter
* \> 4.5 cm
* Those aortic aneurysms \< 4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
* Aorto-iliac aneurysms in which the aortic aneurysm is \< 4.5 cm but the iliac artery aneurysms are \> 3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms \< 3.0 cm.
* Saccular aortic aneurysms \> 3.0 cm.
Aortic Neck
* Diameter \> 17 mm and \< 28 mm (Phase I)
* Diameter \> 14 mm and \< 28 mm (Phase II)
Angulation Neck Length \< 45° \> 15 mm \<60° \> 25 mm
Iliac Arteries
* Diameter \> 8 mm and \< 18 mm (Phase I and Phase II)
* At least one common iliac artery with a cuff \> 15 mm.
Diameter Aortic Neck Common Iliac 26-28 mm 13-18 mm 23-25.9 mm 10-17 mm 20-22.9 mm 9-15 mm 17-19.9 mm 8-13 mm 14-16.9 mm 8-11mm
\*NOTE: An aortic diameter cannot be treated if the iliac diameter is not in the same range (e.g. 26-28 mm aortic necks must be in conjunction with 13-18 mm common iliacs).
Anatomic (surgical controls)
Aortic Aneurysm Diameter
* \> 4.5 cm
* Those aortic aneurysms \<4.5 cm that are at least 1.5 times the diameter of the aorta with a size increase of 5 mm or greater over a six month period will also be included for possible treatment.
* Aorto-iliac aneurysm in which the aortic aneurysm is \<4.5 cm but the iliac artery aneurysm are \>3.0 cm in diameter or there is evidence of recent expansion (5 mm or greater over a six month period) in iliac aneurysms \<3.0 cm.
* Saccular aortic aneurysms \> 3.0 cm.
* Clinical (stent-graft)
* Males and non-pregnant females \> 40 years of age.
* Clinical (surgical controls)
Iliac Arteries
* \< 8 mm and \> 18 mm (native) (Phase I and Phase II)
* Highly calcified (common)
* Neither common iliac artery with a cuff \> 15 mm.
Anatomic (surgical controls)
Exclusion Criteria
Aortic Aneurysm Diameter
· \< 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
Aorto-iliac Aneurysms
* \< 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
* The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate covering both internal iliac arteries with the device.
Aortic Neck
* Diameter \< 17 mm and \> 28 mm (Phase I)
* Diameter \< 14 and \>28 (Phase II)
* Thrombus lined
* Highly calcified
Aortic Aneurysm Diameter
· \< 4.5 cm that are not at least 1.5 times the diameter of the aorta with evidence of a size increase of 5 mm or greater within a six month period.
Aorto-Iliac Aneurysms
* \< 3.0 cm in diameter unless evidence of recent expansion (5 mm or greater within a six month period).
* The iliac portion of the aneurysm extending to the bifurcation bilaterally which would necessitate surgically covering both internal iliac arteries.
Clinical (stent-graft)
1. Ruptured abdominal aortic aneurysm.
2. Renal insufficiency - creatinine level \> 2.5 mg/dl.
40 Years
ALL
No
Sponsors
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Cordis Corporation
INDUSTRY
Principal Investigators
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Michael Marin, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Mt. Sinai Hospital
New York, New York, United States
Countries
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Other Identifiers
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P98-4601
Identifier Type: -
Identifier Source: org_study_id