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Cordis AAA Bilateral Device

Phase 1

Abdominal Aortic Aneurysm | Unknown | Cardiovascular |Cardinal Health, Inc.|Last Updated: Dec 9, 2005

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

Cordis AAA Bilateral Device · 1 trial · 1 indication

Phase 1 1
NCT00235118Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)Abdominal Aortic Aneurysm
COMPLETED29 Analytics
PHASE1COMPLETED
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
Abdominal Aortic Aneurysm
NCT0023511829
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Study Endpoints

Primary Endpoints

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.
The absence of major complications at thirty days defined as arterial thrombosis, respiratory impairment, renal failure, myocardial infarction (M.I.) and stroke in combination with the absence of major complications at one year.

Secondary Endpoints

· 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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Cordis AAA Bilateral DeviceDEVICE -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: \- Anatomic (stent-graft) 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 a...

Countries:United States
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Frequently asked questions about Cordis AAA Bilateral Device

What is the Cordis AAA Bilateral Device used for?

The Cordis AAA Bilateral Device is an investigational medical device being studied for the treatment of abdominal aortic aneurysm, a condition involving a bulging or weakened area in the aorta within the abdomen. It is being evaluated in a clinical trial comparing it to open surgical repair of abdominal aortic aneurysms.

Who is developing the Cordis AAA Bilateral Device?

The Cordis AAA Bilateral Device is being developed by Cardinal Health, Inc., a healthcare company traded on the New York Stock Exchange under the ticker CAH. The device is part of the company's cardiovascular portfolio and is currently in clinical development for abdominal aortic aneurysm.

What phase is the Cordis AAA Bilateral Device in?

The Cordis AAA Bilateral Device is in Phase 1 clinical development. It is an investigational device and has not been approved by regulatory authorities. The device is being studied in a completed early-stage clinical trial for abdominal aortic aneurysm.

What clinical trials is the Cordis AAA Bilateral Device in?

The Cordis AAA Bilateral Device was studied in a completed clinical trial with the identifier NCT00235118, titled 'Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)'. The trial enrolled 29 participants in the United States and included adults aged 40 years and older.

Is the Cordis AAA Bilateral Device the same as the ARIBA device?

The Cordis AAA Bilateral Device is associated with the ARIBA clinical trial, which stands for 'Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms'. The trial name references the device, but no alternative product names have been established for the device itself.