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Carotid Artery Stenting

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment407

FDA Designations

No designations recorded

Clinical trial landscape

Carotid Artery Stenting · 1 trial · 1 indication

Phase 3 1
NCT00417963ViVEXX Carotid Revascularization Trial (VIVA)Carotid Artery Stenosis
COMPLETED407 Analytics
PHASE3COMPLETED
ViVEXX Carotid Revascularization Trial (VIVA)
Carotid Artery StenosisUnlock trial analytics

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 to 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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Frequently asked questions about Carotid Artery Stenting

What is Carotid Artery Stenting used for?

Carotid Artery Stenting is used for the treatment of Carotid Artery Stenosis, a condition characterized by narrowing of the carotid arteries. It is a minimally invasive procedure that involves placing a stent to open the artery and restore proper blood flow, potentially reducing the risk of stroke.

Who makes Carotid Artery Stenting?

Carotid Artery Stenting is developed by Becton, Dickinson and Company, a global medical technology company. The company's stock is traded under the ticker symbol BDX on the New York Stock Exchange.

What phase is Carotid Artery Stenting in?

Carotid Artery Stenting is in Phase 3 clinical development. It is an investigational procedure and has not yet been approved by regulatory authorities. The Phase 3 trial, known as the ViVEXX Carotid Revascularization Trial (VIVA), has been completed.

What clinical trials is Carotid Artery Stenting in?

Carotid Artery Stenting has one completed Phase 3 clinical trial, identified by the NCT number NCT00417963. This trial, titled 'ViVEXX Carotid Revascularization Trial (VIVA)', enrolled 407 participants with Carotid Artery Stenosis. The trial was uncontrolled and not randomized or double-blinded.

Is Carotid Artery Stenting the same as the VIVA procedure?

Carotid Artery Stenting is the procedure evaluated in the ViVEXX Carotid Revascularization Trial (VIVA). The trial, with NCT number NCT00417963, assessed the safety and efficacy of carotid artery stenting in patients with carotid artery stenosis.