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Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)

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Disease Information

Descriptive Information
Brief Title † Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
Official Title † An Evaluation of the Safety and Effectiveness of the Cordis Bilateral AAA Device Compared to Open Surgical Repair for the Treatment of Abdominal Aortic Aneurysm
Brief Summary The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
Detailed Description
Study Phase Phase 1/Phase 2
Study Type † Interventional
Study Design † Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Primary success is defined as freedom from all of the following: rupture of aneurysm, enlargement of aneurysm > 0.5 cm on CT scan, with or without endoleak, as compared to any previous measurement, symptomatic aneurysm requiring treatment.
Secondary Outcome Measure † · Technical success defined as the successful access and deployment of the device at the appropriate anatomic location with aneurysmal exclusion determined by angiography at the time of deployment.
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceCordis AAA Bilateral Device
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 29
Start Date † December 1999
Completion Date February 2006
Primary Completion Date
Eligibility Criteria † Inclusion Criteria: - Anatomic (stent-graft) Aortic Aneurysm Diameter - > 4.5 cm - Those aortic aneurysms 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. Aortic Neck - Diameter > 17 mm and 14 mm and 15 mm 25 mm Iliac Arteries - Diameter > 8 mm and 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) · Surgical controls will be required to meet only the aortic or aorto-iliac aneurysm size requirements for anatomic inclusion criteria. Aortic Aneurysm Diameter - > 4.5 cm - Those aortic aneurysms 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. - Clinical (stent-graft) - Males and non-pregnant females > 40 years of age. - Clinical (surgical controls) Surgical control patients will be required to meet all of the above-stated stent-graft clinical inclusion criteria. Exclusion Criteria: Anatomic (stent-graft) Aortic Aneurysm Diameter · 28 mm (Phase I) - Diameter 28 (Phase II) - Thrombus lined - Highly calcified - NOTE: See inclusion criteria for length below the renals and degree of angulation. Iliac Arteries - 18 mm (native) (Phase I and Phase II) - Highly calcified (common) - Neither common iliac artery with a cuff > 15 mm. - NOTE: See inclusion criteria for aortic neck and iliac artery diameters. Anatomic (surgical controls) · Surgical controls will be excluded based only on the aortic or aorto-iliac aneurysm size requirements for anatomic exclusion criteria. Aortic Aneurysm Diameter · 2.5 mg/dl.
Gender Both
Ages 40 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00235118
Organization ID P98-4601
Secondary IDs ††
Responsible Party
Study Sponsor † Cordis Corporation
Collaborators ††
Investigators † Principal Investigator: Michael Marin, MD, Mt Sinai Hospital, Chicago
Information Provided By
Verification Date October 2005
First Received Date † October 6, 2005
Last Updated Date December 8, 2005
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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