Summary

Location
at Sacramento, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jeffrey Southard, MD

Description

Summary

To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Official Title

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Keywords

Stroke Sentinel® Cerebral Protection System

Eligibility

You can join if…

  • Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
  • Subject has the recommended artery diameter at the site of filter placement per the

Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.

  • Subject (or legal representative) provides written informed consent.

You CAN'T join if...

  • Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
  • Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
  • Subject has compromised blood flow to the right upper extremity.
  • Subject has access vessels with excessive tortuosity.
  • Subject has uncorrected bleeding disorders.
  • Subject is contraindicated for anticoagulant and antiplatelet therapy.

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Kaiser Foundation Hospital - San Francisco accepting new patients
    San Francisco California 94118 United States

Lead Scientist at UC Davis

  • Jeffrey Southard, MD
    Professor, Cardiovascular Medicine. Authored (or co-authored) 30 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
Links
Sign up for this study
ID
NCT04149535
Study Type
Interventional
Last Updated