A Carotid Stenting Boston Scientific Surveillance Program

(CABANA Trial)

Recruiting in Palo Alto (17 mi)

+111 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Boston Scientific Corporation

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.

Research Team

Pamela Grady, Ph.D

Principal Investigator

Boston Scientific Corporation

Eligibility Criteria

Inclusion Criteria

Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.

Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.

Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.

Treatment Details

Interventions

• Carotid WALLSTENT Monorail Endoprosthesis (Endoprosthesis)
• FilterWire EZ™ System™ (Device)

Participant Groups

Group I: Registry Experimental Treatment 2 Interventions

Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology