Carotid.com: Cabana Trial - Clinical Trial Information

Training and Education

The CABANA Trial:
A Carotid Stenting Boston Scientific Surveillance Program

Trial Design:
Multi-center U.S. Surveillance Registry.

Trial Objective:

To compile early clinical outcomes data for the Carotid WALLSTENT® Endoprosthesis and FilterWire EZ™ System in routine clinical practice.
To evaluate clinical outcomes using the death, stroke, and myocardial infarction (MI) rate ≤30 days, in total and by center experience tier.
To assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.

Primary Outcome Measures:
Composite of major adverse events (MAE) defined as center-reported and CEC adjudicated death, stroke, and myocardial infarction (MI) ≤30 days.

Additional Data Analyses:

MAEs by subgroups:

Death (≤30 days)
Stroke (≤30 days)
MI (≤30 days)
Death, stroke and MI (≤24 hours)
Death, stroke and MI (>24 hours and ≤30 days)
Death, stroke and MI (≤30 days) by center experience tier

Adverse events through 30 days: device-related, procedure-related, and events not related to the index procedure or devices.
Target lesion revascularization
Device Malfunction

Eligibility:

Ages Eligible for Study:	18 Years and Older
Genders Eligible for Study	Both
Accepts Healthy Volunteers:	No

Inclusion Criteria:

Patient 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 and meets the criteria below:
- Patient 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
- Patient 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.
Patient has a reference vessel diameter greater between 4.0mm and 9.0mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5mm and less than or equal to 5.5mm as optimal "landing zone" for placement of the FilterWire EZ System.
Patient is willing and able to comply with all follow-up requirements.
Patient has provided a signed informed consent prior to participation in the Registry.

Exclusion Criteria:

Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated.
Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
Patients with uncorrected bleeding disorders.
Lesions in the ostium of the common carotid artery.

Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741091

Contact:
Veronica Pettigrew
veronica.pettigrew@bsci.com

Locations

United States, Louisiana

Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Principal Investigator: Christopher J. White, MD
Recruiting

Source: A Carotid Stenting Boston Scientific Surveillance Program (CABANA) Guideline, Data on File.