Back to resultsCarotid 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
About this trial
This is an interventional supportive care trial for Heart Diseases focused on measuring embolic, filters, brachiocephalic, neurovasculature, debris
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.
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
NCT ID
NCT01484249
First Posted
November 24, 2011
Last Updated
December 2, 2011
Sponsor
Claret Medical
Collaborators
Meditrial Europe Ltd.
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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