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

Stroke Clinical Trial

— OCCLUFLEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069558
• Other study ID #: OCC2021_02
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: October 26, 2026

Study information

• Verified date: March 2024
• Source: Occlutech International AB
• Contact: Susan G. Wiskow
• Phone: 6122839263
• Email: susan.wiskow[@]occlutech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (SAE).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 26, 2026
• Est. primary completion date: October 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Subjects with a PFO and cryptogenic stroke:

• PFO defined as visualization of microbubbles (during Trans Esophageal Echo (TEE)) in the left atrium within three cardiac cycles of right atrial opacification at rest and/or with Valsalva.
• Cryptogenic stroke defined as a stroke of unknown cause.
• Stroke defined as an acute focal neurological deficit, presumed to be due to focal

ischemia, and either:

• Symptoms persisting =24 hours, or symptoms persisting <24 hours with Magnetic Resonance Imaging (MRI) or Computer Tomography (CT) findings of a new, neuroanatomically relevant, cerebral infarct.

Exclusion Criteria:

• Minimum Age: 18 Years and Maximum Age: =50 years.
• Myocardial Infarction (MI) or unstable angina within 6 months.
• Mitral or 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.
• Subjects not able to discontinue anticoagulation.
• Qualifying stroke with Modified Rankin score >3.
• Anatomy in which the device would interfere with intracardiac or vascular structures.
• Life expectancy < 2 years.
• 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: Lupus anticoagulant, anticardiolipin Abs, hyperhomocysteinemia, Cancer-related hypercoagulability.
• 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.

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale
• Stroke

Intervention

Device:
• Investigational PFO Closure Device
Occlutech Flex II PFO Closure Device
• Standard of Care PFO Closure Device
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Locations

Country	Name	City	State
Canada	University of Alberta Mazankowski Heart Institute	Edmonton	Alberta
Canada	Centre Hospitalier de l'Université de Montreal (CHUM)	Montréal	Quebec
Canada	Institut de Cardiologie de Montréal	Montréal	Quebec
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet Copenhagen	Copenhagen
Finland	Heart and Lung Center, Helsinki University Hospital	Helsinki
Germany	CardioVasculäre Centrum Frankfurt	Frankfurt
Germany	Asklepios Klinik Altona Hamburg	Hamburg
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	University Heart Center Lübeck	Lübeck
Netherlands	Amsterdam University Medical Center	Amsterdam
Netherlands	Erasmus University Medical Centre	Rotterdam
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	University Hospitals Sussex	Brighton	East Sussex
United States	University of Michigan	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	Atrium Health Sanger Heart and Vascular Institute	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Essentia Health	Duluth	Minnesota
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	HCA Houston Healthcare Medical Center	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Colorado Heart and Vascular PC / St. Anthony Hospital	Lakewood	Colorado
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	Keck School of Medicine of University of Southern California	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Sentara Health Research Center	Norfolk	Virginia
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	MaineHealth	Portland	Maine
United States	Oregon Health & Science University	Portland	Oregon
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Stanford University Medical Center	Stanford	California
United States	Los Robles Medical Center	Thousand Oaks	California
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: Device and Procedure Related Serious Adverse Events		Enrollment to Twelve Months, Annually thereafter.
Primary	Effective Closure Rate of PFO		Twelve Months
Secondary	Non-Fatal Recurrent Stroke		Enrollment to 12 Months