A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Disease
• Intervention / Treatment: Device: Carotid WALLSTENT Monorail Endoprosthesis; Device: FilterWire EZ™ System™

• Study Type: Interventional
• Enrollment (Actual): 1097
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Baptist Medical Center Princeton
    • Fairhope, Alabama, United States, 36532
      • Cardiology Associates of Mobile
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center, Barrow Neurological Institute
    • Tucson, Arizona, United States, 85741
      • Southern Arizona Vascular Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas
  • California
    • Bakersfield, California, United States, 93308
      • Central Cardiology Medical Clinic
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center
    • Los Angeles, California, United States, 90017
      • Los Angeles Cardiology Associates
    • Newport Beach, California, United States, 92663
      • Hoag Hospital
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System
    • Salinas, California, United States, 93907
      • Salinas Valley Memorial Healthcare System
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Stockton, California, United States, 95204
      • St. Joseph's Medical Center
    • Walnut Creek, California, United States, 94598
      • San Ramon Regional Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center
    • Waterbury, Connecticut, United States, 06708
      • Waterbury Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care Cardiovascular Research
  • Florida
    • Atlantis, Florida, United States, 33462
      • JFK Medical Center
    • Boca Raton, Florida, United States, 33487
      • Delray Medical Center
    • Boynton Beach, Florida, United States, 33435
      • Bethesda Memorial Hospital
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology
    • Fort Lauderdale, Florida, United States, 33308
      • Jim Moran Heart and Vascular Research Institute
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Hollywood, Florida, United States, 33021
      • Aventura Hospital
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Ocala, Florida, United States, 34471
      • MediQuest Research Group Inc at Munroe Regional Medical Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30342
      • St. Joseph's Research Institute
    • Austell, Georgia, United States, 30106
      • Vascular Surgical Associates PC
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Peoria, Illinois, United States, 61637
      • Peoria Radiology Research & Education Foundation
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital, Prairie Education and Research Cooperative
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University - Memorial Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
    • Indianapolis, Indiana, United States, 46250
      • The Indiana Heart Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Hospital
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Physicians and Surgeons Surgical Hospital
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • Opelousas, Louisiana, United States, 70570
      • Opelousas General Health Center
  • Maryland
    • Clinton, Maryland, United States, 20735
      • Southern Maryland Hospital Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Flint, Michigan, United States, 48507
      • Michigan Vascular Research Center
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center
    • St. Joseph, Michigan, United States, 49085
      • Great Lakes Heart and Vascular
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Center
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Freeman Heart & Vascular Institute
    • Joplin, Missouri, United States, 64804
      • St. John's Regional Medical Center
    • Kansas City, Missouri, United States, 64114
      • St. Joseph Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • The Cardiac Center of Creighton University
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Cherry Hill, New Jersey, United States, 08034
      • Our Lady of Lourdes Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • UMDNJ-Robert Wood Johnson Medical School
    • Newark, New Jersey, United States, 07102
      • St. Michael's Medical Center
    • Short Hills, New Jersey, United States, 07078
      • Overlook Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 82102
      • New Mexico Heart Institute, PA
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center Hospital
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Buffalo, New York, United States, 14209
      • Kaleida Health
    • Buffalo, New York, United States, 14221
      • Mercy Hospital of Buffalo
    • Liverpool, New York, United States, 13088
      • St. Joseph Hospital
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Wake Medical Center
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Portsmouth, Ohio, United States, 45662
      • Southern Ohio Medical Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent
    • Willoughby, Ohio, United States, 44094
      • Lake West Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Stroke Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18105
      • LeHigh Valley Hospital
    • Harrisburg, Pennsylvania, United States, 17110
      • Central PA Cardiovascular Research Institute
    • Philadelphia, Pennsylvania, United States, 19106
      • Pennsylvania Hospital of the University of Pennsylvania Health System
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health at Harrisburg Hospital
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiologists, Ltd.
    • Yardley, Pennsylvania, United States, 19067
      • St. Mary Medical Center
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
    • Greenville, South Carolina, United States, 29605
      • University Medical Center - Greenville Memorial Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford USD Medical Center - Sanford Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Memorial Hospital
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Hospital
    • Kingsport, Tennessee, United States, 37660
      • Cardiovascular Associates PC
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Knoxville, Tennessee, United States, 37934
      • Baptist Hospital West
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital-Memphis
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic and Vascular Surgeons (CTVS)
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Dallas, Texas, United States, 75231
      • Presbyterian Hospital of Dallas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Plano, Texas, United States, 75024
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center San Antonio
    • San Antonio, Texas, United States, 78205
      • Peripheral Vascular Associates
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Tacoma, Washington, United States, 98405
      • St. Joseph Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Subject is willing and able to comply with all follow-up requirements.
• Subject 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: Carotid WALLSTENT Monorail Endoprosthesis; A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.; Device: FilterWire EZ™ System™; Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)	Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)	Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.	30 days
Target Lesion Revascularization	Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.	30 days
System Technical Success	System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.	30 days
Device Malfunction	Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.	30 days

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Pamela Grady, Ph.D, Boston Scientific Corporation

Publications and helpful links

General Publications

• Hopkins LN, White CJ, Foster MT, Powell RJ, Zemel G, Diaz-Cartelle J. Carotid artery stenting and patient outcomes: the CABANA surveillance study. Catheter Cardiovasc Interv. 2014 Nov 15;84(6):997-1004. doi: 10.1002/ccd.25578. Epub 2014 Jul 18.
• White CJ, Avula SB, Mintz RT, Iskander A, Chervu A, Feldman RL, Schermerhorn ML, Woo HH, Hopkins LN. Carotid artery revascularization with distal protection in high-surgical-risk patients in routine clinical practice: rationale and design of the CABANA safety surveillance program. Catheter Cardiovasc Interv. 2012 Jan 1;79(1):167-73. doi: 10.1002/ccd.23257. Epub 2011 Oct 5.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 25, 2008
• First Posted (Estimate): August 26, 2008

Study Record Updates

• Last Update Posted (Estimate): August 24, 2011
• Last Update Submitted That Met QC Criteria: August 22, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Stent; Cerebrovascular Disease; Carotid Stent; Carotid Endarterectomy (CEA)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: S2029