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OCCLUFLEX: Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion.

Sponsor
Occlutech International AB (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05069558
Collaborator
(none)
450
Enrollment
4
Locations
2
Arms
53.9
Anticipated Duration (Months)
112.5
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Device: Investigational PFO Closure Device
  • Device: Standard of Care PFO Closure Device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparing Patent Foramen Ovale (PFO) Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion.
Actual Study Start Date :
Apr 30, 2022
Anticipated Primary Completion Date :
Oct 26, 2025
Anticipated Study Completion Date :
Oct 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Investigational PFO Closure Device

PFO closure with the study Occlutech Flex II PFO device.

Device: Investigational PFO Closure Device
Occlutech Flex II PFO Closure Device
Active Comparator: Standard of Care PFO Closure Device

PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.

Device: Standard of Care PFO Closure Device
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder

Outcome Measures

Primary Outcome Measures

  1. Effective Closure Rate of PFO [Twelve Months]

Secondary Outcome Measures

  1. Non-Fatal Recurrent Stroke [Enrollment to 12 Months]

Other Outcome Measures

  1. Safety: Device and Procedure Related Serious Adverse Events [Enrollment to Twelve Months, Annually thereafter.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612
2 Tufts New England Medical Center Boston Massachusetts United States 02111
3 Vanderbilt Medical Center Nashville Tennessee United States 37232
4 Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7

Sponsors and Collaborators

  • Occlutech International AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Occlutech International AB
ClinicalTrials.gov Identifier:
NCT05069558
Other Study ID Numbers:
  • OCC2021_02
First Posted:
Oct 6, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Foramen Ovale, Patent

Study Results

No Results Posted as of Jul 22, 2022