Carotid Filtration During Endovascular Aortic Valve Implantation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Carotid Filtration During Endovascular Aortic Valve Implantation|
- 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). [ Time Frame: From the CE Pro System Insertion Start Time to Final Retrieval Stop Time ] [ Designated as safety issue: No ]
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.
- Transient Ischemia Attack (TIA) Rates [ Time Frame: 30 day follow up ] [ Designated as safety issue: Yes ]The secondary endpoints for this trial are safety endpoints and are presented as adverse events.
|Study Start Date:||February 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Device: CE Pro System
- Gen 2.0
- Gen 2.1
- Gen 2.2
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.