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ViVEXX Carotid Revascularization Trial (VIVA)

Primary Purpose

Carotid Artery Stenosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Carotid Artery Stenting

About this trial

This is an interventional treatment trial for Carotid Artery Stenosis focused on measuring Carotid, Artery, Stenosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stent placement in the carotid artery

Arm Description

placement of a bare metal stent for treatment of carotid artery stenosis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)

Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation

Number of Patients Experiencing Access Site Complications

Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.

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.

Number of Participants Experiencing Device Success

Number of participants with successful delivery and deployment of device with <50% residual stenosis.

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.

Number of Participants Experiencing Restenosis

Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.

Full Information

NCT ID

NCT00417963

First Posted

January 2, 2007

Last Updated

January 17, 2017

Sponsor

C. R. Bard

1. Study Identification

Unique Protocol Identification Number

NCT00417963

Brief Title

ViVEXX Carotid Revascularization Trial (VIVA)

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

C. R. Bard

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Artery Stenosis

Keywords

Carotid, Artery, Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

407 (Actual)

8. Arms, Groups, and Interventions

Arm Title

stent placement in the carotid artery

Arm Type

Experimental

Arm Description

placement of a bare metal stent for treatment of carotid artery stenosis

Intervention Type

Device

Intervention Name(s)

Carotid Artery Stenting

Other Intervention Name(s)

CAS

Intervention Description

placement of a bare metal stent at sites of stenosis in the carotid artery

Primary Outcome Measure Information:

Title

Percentage of Patients Experiencing Major Adverse Events (MAE)

Description

Time Frame

365 days from implantation

Secondary Outcome Measure Information:

Title

Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)

Description

Number of participants experiencing a Target lesion revascularization(s) up to 12 months after implantation

Time Frame

12 months from implantation

Title

Number of Patients Experiencing Access Site Complications

Description

Access site complications requiring blood transfusion (> 1 unit) or open surgical repair.

Time Frame

30 days following implantation

Title

Number of Participants Experiencing Stroke Related Neurologic Deficit

Description

Number of participants experiencing stroke related neurologic deficit persisting at 30 days and attributed to the index procedure.

Time Frame

30 days from implantation

Title

Number of Participants Experiencing Device Success

Description

Number of participants with successful delivery and deployment of device with <50% residual stenosis.

Time Frame

at time of implantation

Title

Number of Participants Experiencing Lesion Success

Description

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.

Time Frame

at time of implantation

Title

Number of Participants Experiencing Restenosis

Description

Number of participants experiencing Restenosis following placement of the ViVexx Carotid Stent.

Time Frame

12 months after implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Rosenfield, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

ViVEXX Carotid Revascularization Trial (VIVA)

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