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Completed

NCT Number: NCT00741091

A Carotid Stenting Boston Scientific Surveillance Program

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.

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Key information

Conditions

Carotid Artery Disease Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baptist Medical Center Princeton, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid WALLSTENT Monorail Endoprosthesis

Device

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™

Device

Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Primary outcomes

  1. 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

    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 outcomes

  1. Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)

    Time frame: 30 days

    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.

  2. Target Lesion Revascularization

    Time frame: 30 days

    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.

  3. System Technical Success

    Time frame: 30 days

    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.

  4. Device Malfunction

    Time frame: 30 days

    Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: CABANA

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 26, 2008
Registry last updated
Aug 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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