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Clinical Trials/NCT04149535
NCT04149535CompletedNot Applicable

PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

Boston Scientific Corporation113 sites in 5 countries3,000 target enrollmentStarted: February 7, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,000
Locations
113
Primary Endpoint
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)

Time Frame: <=72 hours

All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (113)

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