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Carotid Filtration During Endovascular Aortic Valve Implantation

NCT01484249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2011-12-05

No results posted yet for this study

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.

Conditions

  • Heart Diseases

Interventions

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.

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Claret Medical

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, MD, Ph D · Professor of Medicine, Medizinishce Klinik und Poliklinik II, Universitätsklinikum Bonn

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01484249 on ClinicalTrials.gov