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Cerebral Protection Device

Sentinel® Cerebral Protection System for Stroke (PROTECTED TAVR Trial)

N/A
Waitlist Available
Led By Samir Kapadia, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <=72 hours
Awards & highlights

Summary

This trial shows that using the Sentinel® Cerebral Protection System during TAVR significantly reduces the risk of peri-procedural stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~<=72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and <=72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAVR with SentinelExperimental Treatment1 Intervention
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Group II: TAVR without SentinelActive Control1 Intervention
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel® Cerebral Protection System
2020
N/A
~3000

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
724 Previous Clinical Trials
931,123 Total Patients Enrolled
10 Trials studying Stroke
7,033 Patients Enrolled for Stroke
Samir Kapadia, MDPrincipal InvestigatorThe Cleveland Clinic
3 Previous Clinical Trials
1,013 Total Patients Enrolled
~537 spots leftby Sep 2025