Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder

Last updated: November 18, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Blood Clots

Treatment

GORE® CARDIOFORM Septal Occluder

Clinical Study ID

NCT05529901
JPS 21-08
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with cryptogenic stroke (including transient ischemic attack with positivehead imaging findings)

  • Diagnosed with a PFO

  • Note: Additional Inclusion Criteria may apply

Exclusion

Exclusion Criteria:

  • N/A

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: GORE® CARDIOFORM Septal Occluder
Phase:
Study Start date:
October 03, 2022
Estimated Completion Date:
August 31, 2029

Connect with a study center

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama 1854383, 700-8558
    Japan

    Site Not Available

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