Carotid Artery StenosisPhase 3NCT00417963
ViVEXX Carotid Revascularization Trial (VIVA)
A Phase 3 study testing Carotid Artery Stenting in people with Carotid Artery Stenosis, run by C. R. Bard.
Trial summary
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Carotid Artery Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 supplied by the target vessel within 180 days of the procedure.
- Asymptomatic: > than or = to 80% carotid stenosis by angiography without neurological symptoms.
- High risk for carotid endarterectomy: anatomical and co-morbid.
Who cannot join
- History of symptoms of stroke or TIA within 24 hours of the procedure
- Extensive or diffuse atherosclerotic disease
- Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
About this study
Official title: The ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
Read the detailed description
Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Carotid Artery Stenting
- Keywords
- Carotid, Artery, Stenosis
- Medical subject headings
- Carotid Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery StentingDevice
Also called CAS
placement of a bare metal stent at sites of stenosis in the carotid artery
| Study group | Role | What they receive |
|---|---|---|
| stent placement in the carotid artery | Experimental | placement of a bare metal stent for treatment of carotid artery stenosis Receives: Device: Carotid Artery Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Experiencing Major Adverse Events (MAE)
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.
Measured: 365 days from implantation
Secondary outcomes (6)
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation
Measured: 12 months from implantation
Number of Patients Experiencing Access Site Complications
Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.
Measured: 30 days following implantation
Number of Participants Experiencing Stroke Related Neurologic Deficit
Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.
Measured: 30 days from implantation
Number of Participants Experiencing Device Success
Number of participants with successful delivery and deployment of device with <50% residual stenosis.
Measured: at time of implantation
Number of Participants Experiencing Lesion Success
number of participants experiencing achievement of <50% final residual diameter stenosis in the stented segment using the VIVEXX Carotid Stent and the Emboshield Embolic Protection System.
Measured: at time of implantation
Number of Participants Experiencing Restenosis
Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.
Measured: 12 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startOct 2005
- Primary completionJan 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Rosenfield, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417963
- Sponsor's protocol ID
- BPV-VX-1502
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2007
- Last updated
- 1 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System
- ClinicalTrials.gov ID
- NCT00417963
- Acronym / sponsor ID
- BPV-VX-1502
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid, Artery, Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Posted 20 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.
Detailed description
Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stent placement in the carotid artery | Experimental | Device: Carotid Artery Stentingplacement of a bare metal stent for treatment of carotid artery stenosis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:
- High risk for carotid endarterectomy: anatomical and co-morbid.
Key exclusion criteria (3 listed)
- History of symptoms of stroke or TIA within 24 hours of the procedure
- Extensive or diffuse atherosclerotic disease
- Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid Artery StentingAlso: CASplacement of a bare metal stent at sites of stenosis in the carotid artery | Device | stent placement in the carotid artery |
Primary outcome
Percentage of Patients Experiencing Major Adverse Events (MAE)
Time frame: 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.
6 secondary outcomes
Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
Time frame: 12 months from implantation
Number of Patients Experiencing Access Site Complications
Time frame: 30 days following implantation
Number of Participants Experiencing Stroke Related Neurologic Deficit
Time frame: 30 days from implantation
Number of Participants Experiencing Device Success
Time frame: at time of implantation
Number of Participants Experiencing Lesion Success
Time frame: at time of implantation
Number of Participants Experiencing Restenosis
Time frame: 12 months after implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Carotid Artery Stenosis
Not yet recruiting
Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
Carotid Stenosis
Not yet recruitingObservational study
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
Carotid Stenosis
RecruitingObservational study
Perioperative GFAP and Neurological Complications After Carotid Endarterectomy
Carotid Stenosis
Not yet recruiting
Effects of Rosa Roxburghii Tratt Freeze-Dried Powder on Carotid Atherosclerotic Plaques: A Real-World Study
Carotid Artery Plaques, Atherosclerosis
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Rosenfield, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carotid Artery Stenting in people with Carotid Artery Stenosis, run by C. R. Bard.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Experiencing Major Adverse Events (MAE) (time frame: 365 days from implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.