A Carotid Stenting Boston Scientific Surveillance Program (CABANA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00741091
First received: August 25, 2008
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Carotid Artery Disease
Device: Carotid WALLSTENT Monorail Endoprosthesis
Device: FilterWire EZ™ System™
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Target Lesion Revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • System Technical Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  • Device Malfunction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.


Enrollment: 1097
Study Start Date: December 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00741091     History of Changes
Other Study ID Numbers: S2029
Study First Received: August 25, 2008
Results First Received: June 2, 2011
Last Updated: August 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Cerebrovascular Disease
Carotid Stent
Stent
Carotid Endarterectomy (CEA)

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014