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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00235118Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)PHASE1 COMPLETED 29 — — Dec 1, 1999Feb 1, 2006Dec 9, 20051 United States
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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 — 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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