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

Study acronym: OCCLUFLEX
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv28
  2. Study completion date: Oct 26, 2026 to Nov 2029v27
  3. 3 versions Re-verified since Sep 17, 2025, no change to tracked fieldsv24-v26
  4. Start date: Apr 30, 2022 to May 9, 2022v23
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 53 to 48v21
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 54 to 53
    • Primary completion date: Oct 26, 2025 to Nov 30, 2025
    v20
  3. Re-verified, no change to tracked fieldsv19
  4. Site contacts updated at 1 of 54 sitesv18
  5. Study sites: 51 to 54v17
  6. Study sites: 48 to 51v16
  7. Study sites: 47 to 48
    • Eligibility criteria expanded, about 44 words
    v15
  8. Study sites: 46 to 47v14
  9. Study sites: 44 to 46v13
  10. Study sites: 43 to 44v12
  11. Study sites: 42 to 43v11
  12. Study sites: 41 to 42v10
  13. Site contacts updated at 4 of 41 sitesv9
  14. Study sites: 33 to 41v8
  15. Study sites: 30 to 33v7
  16. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 12 to 30
    v6
  17. Study sites: 9 to 12
    • Study title shortened, about 3 words
    v5
  18. Study sites: 4 to 9v4
  19. Study title revisedv3
  20. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 26, 2021 to Apr 30, 2022
    • Study sites: 0 to 4
    • Eligibility criteria expanded, about 5 words
    • Study title shortened, about 3 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Occlutech International AB
10 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Stroke
3,531 trials monitored
See 153 trials at risk
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).
Trial Details
NCT Number NCT05069558
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Stroke, Patent Foramen Ovale, PFO
Related terms Foramen Ovale, Patent, Stroke
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov