SENTINEL Cerebral Protection System post marketing surveillance study

SENTINEL Cerebral Protection System post marketing surveillance study - SENTINEL Cerebral Protection System post marketing surveillance study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055302

Enrollment

200

Registered

2024-10-01

Start date

2025-01-20

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients intended to be treated with SENTINEL Cerebral Protection System

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
Occurrence rate of all stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) though 30 days post TAVR procedure	—

Secondary

Measure	Time frame
-Modified Rankin Scale (mRS) at baseline, post-procedure, 30 days post procedure and AE for stroke -SAE for which relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Device malfunction and adverse event for which the relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Anti-platelet medication and anti- coagulation medication usage from the procedure through 30 days post procedure.	—

Measure

Time frame

-Modified Rankin Scale (mRS) at baseline, post-procedure, 30 days post procedure and AE for stroke -SAE for which relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Device malfunction and adverse event for which the relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Anti-platelet medication and anti- coagulation medication usage from the procedure through 30 days post procedure.

—

Countries

Japan

Contacts

Public ContactHiroshi Sakamoto

Boston Scientific Japan K.K. Clinical Affairs

Hiroshi.Sakamoto@bsci.com03-6853-7500

Outcome results