Clinical Trial

Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

Study acronym: OCCLUFLEX
Active, Not Recruiting
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Summary
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).
Protocol Amendment History 27 amendments
This ClinicalTrials.gov record has been amended 27 times since 2021-09-24; most recent amendment 2026-05-21.
Status change: Recruiting → Active, Not Recruiting 2024-11-25
Status change: Enrolling by Invitation → Recruiting 2023-06-14
Status change: Not Yet Recruiting → Enrolling by Invitation 2022-07-19
Trial Details
NCT Number NCT05069558
Lead Sponsor Occlutech International AB
Conditions Stroke, Patent Foramen Ovale, PFO
Enrollment 450 participants
Start Date 2022-05-09
Primary Completion 2025-11-30 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-22