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 Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Device: CE Pro System

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the CE Pro System Insertion Start Time to Final Retrieval Stop Time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transient Ischemia Attack (TIA) Rates	The secondary endpoints for this trial are safety endpoints and are presented as adverse events.	30 day follow up

Collaborators and Investigators

• Sponsor: Claret Medical
• Collaborators: Meditrial Europe Ltd.
• Investigators: Principal Investigator: Eberhard Grube, MD, Ph D, Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimate): December 2, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2011
• Last Update Submitted That Met QC Criteria: December 2, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: embolic; filters; brachiocephalic; neurovasculature; debris
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CMP 001b