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Carotid Filtration During Endovascular Aortic Valve Implantation

Primary Purpose

Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CE Pro System
Sponsored by
Claret Medical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Diseases focused on measuring embolic, filters, brachiocephalic, neurovasculature, debris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must be scheduled to undergo an endovascular aortic valve prosthesis implant procedure with the femoral artery as the intended access site for the valve delivery system.
  • Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure.
  • Subject's left carotid artery and innominate artery diameters must be compatible with the Claret CE Pro System sizes available for the procedure (refer to package labeling for appropriate sizing information).
  • Subject must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.

Exclusion Criteria:

  • Subject requires an emergent procedure.
  • Subject has carotid artery stenosis >70% in either carotid artery.
  • Subject innominate or left carotid artery reveals significant stenosis, ectasia, dissection or aneurysm at the ostium or within 3 cm of the ostium.
  • Subject has allergy to materials from which the device is constructed (Nitinol, fluorinated ethylene-propylene, polyamide, polyimide, platinum, iridium, stainless steel, cyanoacrylate adhesives, polycarbonate, polyethylene, polyester, polyurethane, PTFE [poly-tetrafluoroethylene], polydimethylsiloxane [lubricant coating], silicone, polyetheretherketone, tin-silver [solder] or acrylated urethane adhesives)
  • Subject has a history of bleeding diatheses or coagulopathy or will refuse blood transfusion in cases of emergency.
  • Subject has renal insufficiency, defined as a creatinine level > 2.5 mg/dl at the time of treatment, unless subject is on chronic hemodialysis.
  • Subject has hyperthyroidism.
  • Subject suffered recent (within the past 3 months) stroke with permanent deficit.
  • Subject suffered recent (within the past 6 months) significant gastrointestinal (GI) bleed.
  • Subject is involved in another clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.
  • Subject history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, Clopidogrel, or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Primary endpoint is technical success of the CE Pro System to deliver, retrieve proximal & distal filters during an endovascular procedure such as Transcatheter aortic valve implantation (TAVI).
    Technical success defined as, successful delivery & retrieval of the proximal & distal filters. The following Operator feedback was collected & used to evaluate the primary endpoint. Operators are asked to record, the indwelling time for the CE Pro System was used. Calculated as duration from the CE Pro System Insertion Start Time to Final Retrieval Stop Time. Operators are asked to rate the CE Pro Systems performance based on a scale of 1 to 5, with 5 being the highest rating.

    Secondary Outcome Measures

    Transient Ischemia Attack (TIA) Rates
    The secondary endpoints for this trial are safety endpoints and are presented as adverse events.

    Full Information

    First Posted
    November 24, 2011
    Last Updated
    December 2, 2011
    Sponsor
    Claret Medical
    Collaborators
    Meditrial Europe Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01484249
    Brief Title
    Carotid Filtration During Endovascular Aortic Valve Implantation
    Official Title
    Carotid Filtration During Endovascular Aortic Valve Implantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Claret Medical
    Collaborators
    Meditrial Europe Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was designed as a First In Man (FIM) trial to evaluate the feasibility and technical capability of the Claret CE Pro System in delivering two embolic filters to the brachiocephalic artery and the left common carotid artery during a Transcatheter aortic valve implantation (TAVI) procedure in order to protect the neurovasculature from debris liberated during the procedure.
    Detailed Description
    Transcatheter aortic valve implantation (TAVI) is a recently developed procedure whereby a prosthetic aortic valve is implanted percutaneously, and the procedure has demonstrated promising results in high risk surgical populations. TAVI currently requires the use of large bore (18-26F) catheter delivery systems that are often difficult to deliver to over the aortic arch to the aortic annulus. Available data indicate that TAVI is associated with a 4-12% procedural stroke rate and approximately 10% procedural mortality. It has been suggested that these strokes are most likely caused by the liberation of embolic debris either when the TAVI delivery catheter is advanced over the aortic arch or during the actual valve deployment. Given this situation, the availability of devices able to protect both hemispheres of the brain from potentially embolic debris during the TAVI procedure is an emerging clinical need. Claret Medical has developed a technology to provide protection to the neurovascular system during TAVI and other valve repair procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases
    Keywords
    embolic, filters, brachiocephalic, neurovasculature, debris

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    CE Pro System
    Other Intervention Name(s)
    Gen 2.0, Gen 2.1, Gen 2.2
    Intervention Description
    The CE Pro System consists of a delivery catheter with an integrated proximal filter intended to be deployed in the brachiocephalic artery. In addition, the device has an articulating distal tip and a through lumen to allow a commercial intravascular filter to be back-loaded into the CE Pro System and be deployed into and retrieved from the left carotid artery.
    Primary Outcome Measure Information:
    Title
    Primary endpoint is technical success of the CE Pro System to deliver, retrieve proximal & distal filters during an endovascular procedure such as Transcatheter aortic valve implantation (TAVI).
    Description
    Technical success defined as, successful delivery & retrieval of the proximal & distal filters. The following Operator feedback was collected & used to evaluate the primary endpoint. Operators are asked to record, the indwelling time for the CE Pro System was used. Calculated as duration from the CE Pro System Insertion Start Time to Final Retrieval Stop Time. Operators are asked to rate the CE Pro Systems performance based on a scale of 1 to 5, with 5 being the highest rating.
    Time Frame
    From the CE Pro System Insertion Start Time to Final Retrieval Stop Time
    Secondary Outcome Measure Information:
    Title
    Transient Ischemia Attack (TIA) Rates
    Description
    The secondary endpoints for this trial are safety endpoints and are presented as adverse events.
    Time Frame
    30 day follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be scheduled to undergo an endovascular aortic valve prosthesis implant procedure with the femoral artery as the intended access site for the valve delivery system. Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure. Subject's left carotid artery and innominate artery diameters must be compatible with the Claret CE Pro System sizes available for the procedure (refer to package labeling for appropriate sizing information). Subject must have been informed of the nature of the study, agree to its provisions, and provide written informed consent. Exclusion Criteria: Subject requires an emergent procedure. Subject has carotid artery stenosis >70% in either carotid artery. Subject innominate or left carotid artery reveals significant stenosis, ectasia, dissection or aneurysm at the ostium or within 3 cm of the ostium. Subject has allergy to materials from which the device is constructed (Nitinol, fluorinated ethylene-propylene, polyamide, polyimide, platinum, iridium, stainless steel, cyanoacrylate adhesives, polycarbonate, polyethylene, polyester, polyurethane, PTFE [poly-tetrafluoroethylene], polydimethylsiloxane [lubricant coating], silicone, polyetheretherketone, tin-silver [solder] or acrylated urethane adhesives) Subject has a history of bleeding diatheses or coagulopathy or will refuse blood transfusion in cases of emergency. Subject has renal insufficiency, defined as a creatinine level > 2.5 mg/dl at the time of treatment, unless subject is on chronic hemodialysis. Subject has hyperthyroidism. Subject suffered recent (within the past 3 months) stroke with permanent deficit. Subject suffered recent (within the past 6 months) significant gastrointestinal (GI) bleed. Subject is involved in another clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation. Subject history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, Clopidogrel, or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eberhard Grube, MD, Ph D
    Organizational Affiliation
    Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Carotid Filtration During Endovascular Aortic Valve Implantation

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