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

Stroke Clinical Trial

Official title:
Prospective Randomized Multi-center Controlled Clinical Investigation Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05069558
Study type Interventional
Source Occlutech International AB
Contact Susan G. Wiskow
Phone 6122839263
Email susan.wiskow@occlutech.com
Status Recruiting
Phase N/A
Start date April 30, 2022
Completion date October 26, 2026
View Details
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