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Carotid Artery Stenting

Phase 3

Carotid Artery Stenosis | Unknown | Other |Becton, Dickinson and Company|Last Updated: Mar 1, 2017

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment407
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00417963ViVEXX Carotid Revascularization Trial (VIVA)PHASE3 COMPLETED 407Oct 1, 2005Mar 1, 2010Mar 1, 2017 -
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Study Endpoints
Primary Endpoints
Percentage of Patients Experiencing Major Adverse Events (MAE)
365 days from implantation

A composite of major adverse events (MAE) including any death, any stroke and/or myocardial infarction occurring during the first 30 days post-procedure and ipsilateral stroke between 31 and 365 days post procedure.

Secondary Endpoints
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
12 months from implantation
Number of Patients Experiencing Access Site Complications
30 days following implantation
Number of Participants Experiencing Stroke Related Neurologic Deficit
30 days from implantation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
stent placement in the carotid arteryEXPERIMENTALplacement of a bare metal stent for treatment of carotid artery stenosis
Interventions
NameTypeDescription
Carotid Artery StentingDEVICEplacement of a bare metal stent at sites of stenosis in the carotid artery
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria: * Symptomatic: \> than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere suppli...

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