Carotid Filtration During Endovascular Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Heart Diseases

Keywords

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embolic filters brachiocephalic neurovasculature debris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Gen 2.0 Gen 2.1 Gen 2.2

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eberhard Grube, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn

Other Identifiers

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CMP 001b

Identifier Type: -

Identifier Source: org_study_id