Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active NA study of Stroke and Patent Foramen Ovale, sponsored by Occlutech International AB.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05069558 still lists
NCT05069558 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (96% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05069558's enrollment target sits among peer trials
450 61st of 454 higher than 393 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Tracking a Tactile Signal Along the Nervous System
RECRUITING · NA
-
Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
RECRUITING · NA
-
Strategy Training for Individuals With Unilateral Neglect
RECRUITING · NA
-
Weight Loss and ExeRcise
RECRUITING · NA
-
Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
RECRUITING · NA
-
Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00515060 · 450 participants
Psychophysical Studies of Cancer Therapy Pain
- NCT01257269 · 450 participants
Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome)
- NCT03047161 · 450 participants
Electrophysiology of Fetal Arrhythmia
- NCT03269630 · 450 participants
New Orleans Pulmonary Hypertension Biobank
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI