StrokeOCCLUFLEXNCT05069558
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
A study testing Investigational PFO Closure Device in people with Stroke and Patent Foramen Ovale, run by Occlutech International AB at 48 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Patent Foramen Ovale, PFO
- What is being tested?
- Investigational PFO Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 48 sitesin 8 countries
- Study dates
- 9 May 2022to Nov 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age < 18 years
- Myocardial Infarction (MI) or unstable angina within 6 months.
- Severe mitral valve stenosis, severe aortic valve stenosis, or severe regurgitation.
- Left Ventricle Ejection Fraction (LVEF) <35%.
- Uncontrolled hypertension or diabetes mellitus despite medications.
- Subjects contraindicated for aspirin or clopidogrel.
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- Presence of other comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.
- Qualifying stroke with Modified Rankin score >3.
- Anatomy in which the device would interfere with intracardiac or vascular structures.
- Life expectancy < 2 years.
- Participation in another clinical study that can interfere with the results of this study
- Exclusion for patients with known causes of ischemic stroke:
- Atrial fibrillation/atrial flutter (chronic or intermittent).
- Left Ventricle (LV) aneurysm, intracardiac thrombus, or tumor.
- Mitral or aortic valve vegetation or prosthesis.
- Aortic arch plaques protruding >4 mm into the lumen.
- Atherosclerosis or arteriopathy of intra- or extracranial vessels with >50% diameter stenosis in the artery supplying the infarcted territory.
- Another cause of right-to-left shunting (e.g., an Atrial Septal Defect (ASD) or a fenestrated atrial septum).
- Presence of an arterial hypercoagulable state.
- Lacunar infarct probably due to intrinsic small vessel as the qualifying event, defined as an ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following:
- A history of hypertension (except in the first week post stroke).
- A history of diabetes mellitus.
- Age ≥50 years.
- MRI or CT with leukoaraiosis greater than symmetric, well-defined periventricular caps, or bands (European Task Force on Age-Related White Matter Changes rating scale score >0).
- Arterial dissection as the qualifying event.
Trial locations and contacts
48 sites in 8 countries.
48 sites in 8 countries
United States27 sites
University of Michigan
Ann Arbor, Michigan, 48109
Tufts New England Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Essentia Health
Duluth, Minnesota, 55804
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Colorado Heart and Vascular PC / St. Anthony Hospital
Lakewood, Colorado, 80228
South Denver Cardiology Associates
Littleton, Colorado, 80120
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
University of Nebraska Medical Center
Omaha, Nebraska, 68198
The Valley Hospital
Paramus, New Jersey, 07652
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
MaineHealth
Portland, Maine, 04102
Oregon Health & Science University
Portland, Oregon, 97239
Baystate Medical Center
Springfield, Massachusetts, 01199
Stanford University Medical Center
Stanford, California, 94305
Los Robles Medical Center
Thousand Oaks, California, 91360
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Canada6 sites
University of Alberta Mazankowski Heart Institute
Edmonton, Alberta
Centre Hospitalier de l'Université de Montreal (CHUM)
Montreal, Quebec
Institut de Cardiologie de Montréal
Montreal, Quebec
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Toronto General Hospital
Toronto, Ontario
Vancouver General Hospital
Vancouver, British Columbia
Germany5 sites
CardioVasculäre Centrum Frankfurt
Frankfurt, 60389
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Altona Hamburg
Hamburg, 22763
Universitätsklinik Heidelberg
Heidelberg
University Heart Center Lübeck
Lübeck, 23538
France3 sites
CHU Grenoble Alpes
La Tronche, 38700
Hôpital Privé Jacques Cartier
Massy, 91300
CHU Toulouse Rangueil
Toulouse, 31400
Denmark2 sites
Aarhus University Hospital
Aarhus
Rigshospitalet Copenhagen
Copenhagen, 2100
Netherlands2 sites
Amsterdam University Medical Center
Amsterdam
Erasmus University Medical Centre
Rotterdam
United Kingdom2 sites
Royal Victoria Hospital
Belfast
University Hospitals Sussex
Brighton, East Sussex
About this study
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
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
- Stroke, Patent Foramen Ovale, PFO
- Being tested
- Investigational PFO Closure Device, Standard of Care PFO Closure Device
- Medical subject headings
- Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational PFO Closure DeviceDevice
Occlutech Flex II PFO Closure Device
Standard of Care PFO Closure DeviceDevice
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder
| Study group | Role | What they receive |
|---|---|---|
| Investigational PFO Closure Device | Experimental | PFO closure with the study Occlutech Flex II PFO device. Receives: Device: Investigational PFO Closure Device |
| Standard of Care PFO Closure Device | Active comparator | PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder. Receives: Device: Standard of Care PFO Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Closure Rate of PFO
Measured: Twelve Months
Secondary outcomes (1)
Non-Fatal Recurrent Stroke
Measured: Enrollment to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start9 May 2022
- Primary completion30 Nov 2025
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Thaler, MD, PhD, FAHA, Study chair, Tufts Medical Center and Tufts University School of MedicineSteven Yakubov, MD, FACC, MSCAI, Study chair, OhioHealth Heart & Vascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069558
- Sponsor's protocol ID
- OCC2021_02
- Acronym
- OCCLUFLEX
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No