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Trial record 5 of 16 for:    occlutech

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069558
Recruitment Status : Enrolling by invitation
First Posted : October 6, 2021
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Occlutech International AB

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
Stroke Patent Foramen Ovale Device: Investigational PFO Closure Device Device: Standard of Care PFO Closure Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 30, 2022
Estimated Primary Completion Date : October 26, 2025
Estimated Study Completion Date : October 26, 2026

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




Primary Outcome Measures :
  1. Effective Closure Rate of PFO [ Time Frame: Twelve Months ]

Secondary Outcome Measures :
  1. Non-Fatal Recurrent Stroke [ Time Frame: Enrollment to 12 Months ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069558


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
Occlutech International AB
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Responsible Party: Occlutech International AB
ClinicalTrials.gov Identifier: NCT05069558    
Other Study ID Numbers: OCC2021_02
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities