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

Running, not enrolling · Not applicable

Conditions studied: Stroke, Patent Foramen Ovale, PFO

In brief

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).

Key facts

Study ID

NCT05069558

Run by

Occlutech International AB

People needed

450

Starts

2022-05-09

Expected to finish

2029-11-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.

Where it is running

• Hôpital Privé Jacques Cartier — Massy, France
• CHU Toulouse Rangueil — Toulouse, France
• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Stanford University Medical Center — Stanford, California, United States
• Los Robles Medical Center — Thousand Oaks, California, United States
• Colorado Heart and Vascular PC / St. Anthony Hospital — Lakewood, Colorado, United States
• South Denver Cardiology Associates — Littleton, Colorado, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• University of Louisville — Louisville, Kentucky, United States
• MaineHealth — Portland, Maine, United States
• Tufts New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Essentia Health — Duluth, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• The Valley Hospital — Paramus, New Jersey, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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