OCCUFLEX

• Research type

  Research Study

• Full title

  Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion

• IRAS ID

  318613

• Contact name

  David Hildick-Smith

• Contact email

  david.hildick-smith@nhs.net

• Sponsor organisation

  Occlutech US LLC

• Clinicaltrials.gov Identifier

  NCT05069558

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  The OCCLUFLEX PFO Study is a regulated prospective, randomized, multicenter clinical investigation comparing the Flex II PFO Occluder investigational device to the market approved Amplatzer PFO Occluder and Gore Cardioform PFO Occluder devices. Patients will be gathered from the investigators pool of cryptogenic stroke patients who have a PFO. A 1:1 electronic randomization scheme in the EDC system will be used to minimize risk of bias in the investigation. Patients will undergo standard of care PFO closure to minimize risk of adverse device effects.
  To be consistent with the previously approved PFO Occluders, the same endpoint definitions for the primary endpoint of PFO closure and secondary endpoint of stroke will be used in this study. In addition, the safety evaluation will be the same as previous studies

• REC name

  South West - Frenchay Research Ethics Committee

• REC reference

  22/SW/0156

• Date of REC Opinion

  17 Feb 2023

• REC opinion

  Further Information Favourable Opinion