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NCT05069558 · ClinicalTrials.gov registry record · NA
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
A NA study of Stroke and Patent Foramen Ovale, sponsored by Occlutech International AB.
- Active
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05069558 is a NA study of Stroke and Patent Foramen Ovale that is active but no longer recruiting, run by Occlutech International AB. The registered enrollment target is 450 participants, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT05069558, a NA study of Stroke and Patent Foramen Ovale, is active but no longer recruiting, sponsored by Occlutech International AB.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DEVICE Investigational PFO Closure Device
- DEVICE Standard of Care PFO Closure Device
Study Locations (20)
Massachusetts
- Tufts New England Medical Center - Boston
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Baystate Medical Center - Springfield
California
- Stanford University Medical Center - Stanford
- Los Robles Medical Center - Thousand Oaks
Colorado
- Colorado Heart and Vascular PC / St. Anthony Hospital - Lakewood
- South Denver Cardiology Associates - Littleton
Illinois
- Rush University Medical Center - Chicago
- OSF Saint Francis Medical Center - Peoria
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- The Ohio State University - Columbus
Arizona
- Arizona Cardiovascular Research Center - Phoenix
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2029-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05069558
The ClinicalTrials.gov registry entry for NCT05069558 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (96% lower). The listed sponsor is Occlutech International AB, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Investigational PFO Closure Device is the first listed.
NCT05069558 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Massachusetts, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05069558 about?
NCT05069558 is a clinical study titled "Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion". 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 Serio...
What is the current status of trial NCT05069558?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2022-05-09. Estimated completion is 2029-11.
What conditions does trial NCT05069558 study?
This clinical trial studies the following conditions: Stroke, Patent Foramen Ovale, PFO.
What interventions are being tested in trial NCT05069558?
The interventions under investigation include: Investigational PFO Closure Device (DEVICE), Standard of Care PFO Closure Device (DEVICE).
Who is sponsoring clinical trial NCT05069558?
This trial is sponsored by Occlutech International AB, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05069558 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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