A Carotid Stenting Boston Scientific Surveillance Program

Carotid Artery Disease Clinical Trial

— CABANA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741091
• Other study ID #: S2029
• Status: Completed
• Phase: Phase 4
• First received: August 25, 2008
• Last updated: August 22, 2011
• Start date: December 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1097
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

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.
• FilterWire EZ™ System™
Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Locations

Country	Name	City	State
United States	Albany Medical Center Hospital	Albany	New York
United States	New Mexico Heart Institute, PA	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph's Research Institute	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	University of Colorado Hospital	Aurora	Colorado
United States	Vascular Surgical Associates PC	Austell	Georgia
United States	Cardiothoracic and Vascular Surgeons (CTVS)	Austin	Texas
United States	Central Cardiology Medical Clinic	Bakersfield	California
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	Delray Medical Center	Boca Raton	Florida
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Bradenton Cardiology	Bradenton	Florida
United States	Maimonides Medical Center	Brooklyn	New York
United States	Kaleida Health	Buffalo	New York
United States	Mercy Hospital of Buffalo	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Erlanger Hospital	Chattanooga	Tennessee
United States	Memorial Hospital	Chattanooga	Tennessee
United States	Our Lady of Lourdes Medical Center	Cherry Hill	New Jersey
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Southern Maryland Hospital Center	Clinton	Maryland
United States	South Carolina Heart Center	Columbia	South Carolina
United States	Grant Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Cardiology Associates of Mobile	Fairhope	Alabama
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Michigan Vascular Research Center	Flint	Michigan
United States	Jim Moran Heart and Vascular Research Institute	Fort Lauderdale	Florida
United States	University of Florida	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	University Medical Center - Greenville Memorial Hospital	Greenville	South Carolina
United States	Central PA Cardiovascular Research Institute	Harrisburg	Pennsylvania
United States	Aventura Hospital	Hollywood	Florida
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	The Indiana Heart Hospital	Indianapolis	Indiana
United States	Freeman Heart & Vascular Institute	Joplin	Missouri
United States	St. John's Regional Medical Center	Joplin	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Cardiovascular Associates PC	Kingsport	Tennessee
United States	Baptist Hospital West	Knoxville	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas	Little Rock	Arkansas
United States	St. Joseph Hospital	Liverpool	New York
United States	Los Angeles Cardiology Associates	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Norton Hospital	Louisville	Kentucky
United States	Baptist Memorial Hospital-Memphis	Memphis	Tennessee
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Miami Hospital	Miami	Florida
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Physicians and Surgeons Surgical Hospital	Monroe	Louisiana
United States	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Christiana Care Cardiovascular Research	Newark	Delaware
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Hoag Hospital	Newport Beach	California
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	MediQuest Research Group Inc at Munroe Regional Medical Center	Ocala	Florida
United States	The Cardiac Center of Creighton University	Omaha	Nebraska
United States	Opelousas General Health Center	Opelousas	Louisiana
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Peoria Radiology Research & Education Foundation	Peoria	Illinois
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Pennsylvania Hospital of the University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center, Barrow Neurological Institute	Phoenix	Arizona
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Stroke Center	Portland	Oregon
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Wake Medical Center	Raleigh	North Carolina
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Covenant Medical Center	Saginaw	Michigan
United States	Salinas Valley Memorial Healthcare System	Salinas	California
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Swedish Medical Center	Seattle	Washington
United States	Overlook Hospital	Short Hills	New Jersey
United States	Sanford USD Medical Center - Sanford Clinical Research	Sioux Falls	South Dakota
United States	Southern Illinois University - Memorial Medical Center	Springfield	Illinois
United States	St. John's Hospital, Prairie Education and Research Cooperative	Springfield	Illinois
United States	Great Lakes Heart and Vascular	St. Joseph	Michigan
United States	St. Joseph's Medical Center	Stockton	California
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	St. Joseph Hospital	Tacoma	Washington
United States	Tallahassee Research Institute, Inc.	Tallahassee	Florida
United States	Mercy St. Vincent	Toledo	Ohio
United States	University of Toledo Medical Center	Toledo	Ohio
United States	Southern Arizona Vascular Institute	Tucson	Arizona
United States	San Ramon Regional Medical Center	Walnut Creek	California
United States	Waterbury Hospital	Waterbury	Connecticut
United States	Lake West Hospital	Willoughby	Ohio
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania
United States	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania
United States	St. Mary Medical Center	Yardley	Pennsylvania
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Device Malfunction	Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.	30 days	Yes