Phase 3
N=486
ViVEXX Carotid Revascularization Trial (VIVA)
Carotid Artery Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00417963 ↗Enrolled (actual)
486
Serious AEs
65.0%
Results posted
Jul 2011
Primary outcome: Primary: Percentage of Patients Experiencing Major Adverse Events (MAE) — 6.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carotid Artery Stenting (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Experiencing Major Adverse Events (MAE) |
6.9 | — |
| SECONDARY Number of Participants Experiencing Target Lesion Revascularization(s) (TLR) |
19; 2; 17 | — |
| SECONDARY Number of Patients Experiencing Access Site Complications |
8; 1; 7 | — |
| SECONDARY Number of Participants Experiencing Stroke Related Neurologic Deficit |
11; 1; 10 | — |
| SECONDARY Number of Participants Experiencing Device Success |
462; 462 | — |
| SECONDARY Number of Participants Experiencing Lesion Success |
473 | — |
| SECONDARY Number of Participants Experiencing Restenosis |
68; 43 | — |
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.
Eligibility Criteria
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 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00417963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.