Carotid Filtration During Endovascular Aortic Valve Implantation
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|ClinicalTrials.gov Identifier: NCT01484249|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : December 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases||Device: CE Pro System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Carotid Filtration During Endovascular Aortic Valve Implantation|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
- Device: CE Pro System
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.Other Names:
- Gen 2.0
- Gen 2.1
- Gen 2.2
- 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 ]
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 ]The secondary endpoints for this trial are safety endpoints and are presented as adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484249
|Principal Investigator:||Eberhard Grube, MD, Ph D||Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn|