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

Primary Purpose

Stroke, Patent Foramen Ovale

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Investigational PFO Closure Device
Standard of Care PFO Closure Device
Sponsored by
Occlutech International AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University Medical CenterRecruiting
  • Los Robles Medical CenterRecruiting
  • Colorado Heart and Vascular PC / St. Anthony HospitalRecruiting
  • South Denver Cardiology AssociatesRecruiting
  • Medstar Washington Hospital CenterRecruiting
  • Rush University Medical CenterRecruiting
  • University of LouisvilleRecruiting
  • Cardiovascular Institute of the SouthRecruiting
  • Tufts New England Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Baystate Medical CenterRecruiting
  • University of MichiganRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Ohio Health Research InstituteRecruiting
  • Oklahoma Heart HospitalRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Vanderbilt Medical CenterRecruiting
  • HCA Houston Healthcare Medical CenterRecruiting
  • University of Texas Health Science Center at HoustonRecruiting
  • Sentara Health Research Center
  • Vancouver General HospitalRecruiting
  • Ottawa Heart Institute
  • Toronto General HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Rigshospitalet CopenhagenRecruiting
  • CardioVasculäre Centrum FrankfurtRecruiting
  • Universitaetsklinikum Hamburg-EppendorfRecruiting
  • Asklepios Klinik Altona HamburgRecruiting
  • University Heart Center LübeckRecruiting
  • Amsterdam University Medical CenterRecruiting
  • Erasmus University Medical CentreRecruiting
  • University Hospitals SussexRecruiting
  • Royal Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational PFO Closure Device

Standard of Care PFO Closure Device

Arm Description

PFO closure with the study Occlutech Flex II PFO device.

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

Outcomes

Primary Outcome Measures

Effective Closure Rate of PFO

Secondary Outcome Measures

Non-Fatal Recurrent Stroke

Full Information

First Posted
September 24, 2021
Last Updated
August 10, 2023
Sponsor
Occlutech International AB
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1. Study Identification

Unique Protocol Identification Number
NCT05069558
Brief Title
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
October 26, 2025 (Anticipated)
Study Completion Date
October 26, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Occlutech International AB

4. Oversight

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
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Patent Foramen Ovale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational PFO Closure Device
Arm Type
Experimental
Arm Description
PFO closure with the study Occlutech Flex II PFO device.
Arm Title
Standard of Care PFO Closure Device
Arm Type
Active Comparator
Arm Description
PFO closure with either of the standard of care PFO occlusion devices; Amplatzer PFO Occluder or the Gore Cardioform PFO Occluder.
Intervention Type
Device
Intervention Name(s)
Investigational PFO Closure Device
Intervention Description
Occlutech Flex II PFO Closure Device
Intervention Type
Device
Intervention Name(s)
Standard of Care PFO Closure Device
Intervention Description
Amplatzer PFO Occluder and Gore Cardioform PFO Occluder
Primary Outcome Measure Information:
Title
Effective Closure Rate of PFO
Time Frame
Twelve Months
Secondary Outcome Measure Information:
Title
Non-Fatal Recurrent Stroke
Time Frame
Enrollment to 12 Months
Other Pre-specified Outcome Measures:
Title
Safety: Device and Procedure Related Serious Adverse Events
Time Frame
Enrollment to Twelve Months, Annually thereafter.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan G. Wiskow
Phone
6122839263
Email
susan.wiskow@occlutech.com
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Perlas
First Name & Middle Initial & Last Name & Degree
David Lee, MD
Facility Name
Los Robles Medical Center
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saibal Kar, MD
Facility Name
Colorado Heart and Vascular PC / St. Anthony Hospital
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nima Aghili, MD
Facility Name
South Denver Cardiology Associates
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee MacDonald, MD
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Jackman
First Name & Middle Initial & Last Name & Degree
Lowell Satler, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nusrat Jahan
First Name & Middle Initial & Last Name & Degree
Fareed Moses Collado, MD, FACC, FSCAI
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Moore
Email
jennifer.burnett.2@louisville.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Copeland, RN, BSN
Email
stephanie.copeland@uoflhealth.org
First Name & Middle Initial & Last Name & Degree
Naresh Solankhi, MD
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monique Robert
Phone
985-873-4189
First Name & Middle Initial & Last Name & Degree
Peter Fail
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Lynch
First Name & Middle Initial & Last Name & Degree
David Thaler
First Name & Middle Initial & Last Name & Degree
Carey Kimmelstiel
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Yang
Phone
646-371-6868
First Name & Middle Initial & Last Name & Degree
Ada Stefanescu
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Callahan
Email
Christine.callahan@baystatehealth.org
First Name & Middle Initial & Last Name & Degree
Andrew Goldsweig, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gau Shoua Vue
Email
gaushouv@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Allison Schley
Email
schleya@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Gunzenhauser
First Name & Middle Initial & Last Name & Degree
Edward O'Leary, MD
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urmila Gnyawali
Phone
614-566-1263
First Name & Middle Initial & Last Name & Degree
Carlos Sanchez
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacie Hanes, APRN-CNS
Email
shanes@okheart.com
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Pattle
Phone
503-494-7191
First Name & Middle Initial & Last Name & Degree
Wayne Clark
Facility Name
Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherry Bowman
First Name & Middle Initial & Last Name & Degree
Robert Piana
Facility Name
HCA Houston Healthcare Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Morrison
Email
Joan.Morrison@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Pranav Loyalka, MD
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Menezes
Email
anna.m.menezes@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Ken Chan
Email
Ken.Y.Chan@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Abhijeet Dhoble
Facility Name
Sentara Health Research Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Withdrawn
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Himantha De Silva
Email
Himantha.desilva@vch.ca
First Name & Middle Initial & Last Name & Degree
Naomi Uchida
Email
Naomi.uchida@ubc.ca
First Name & Middle Initial & Last Name & Degree
David Wood, MD
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Wasiak
Email
Anna.Wasiak@uhn.ca
First Name & Middle Initial & Last Name & Degree
Eric Horlick, MD
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asger Andersen
Email
asger.andersen@clin.au.dk
First Name & Middle Initial & Last Name & Degree
Jens Erik Nielsen-Kudsk, Prof.
Facility Name
Rigshospitalet Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schmidt, MD
Facility Name
CardioVasculäre Centrum Frankfurt
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine de Bruijn
Email
s.debruijn@cvcfrankfurt.de
First Name & Middle Initial & Last Name & Degree
Horst Sievert, Prof. Dr. med.
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Schofer, MD
Facility Name
Asklepios Klinik Altona Hamburg
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Meincke, MD
Facility Name
University Heart Center Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr. med.
Email
Ingo.Eitel@uksh.de
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr. med.
Facility Name
Amsterdam University Medical Center
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Witte
Email
l.s.witte@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Robbert de Winter, MD, PhD, FESC
Facility Name
Erasmus University Medical Centre
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas van Mieghem, Prof
Email
n.vanmieghem@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Jeroen Wilschut, MD
Email
j.wilschut@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Nicolas van Mieghem, Prof.
Facility Name
University Hospitals Sussex
City
Brighton
State/Province
East Sussex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ailie Mackenzie
Email
ailie.mackenzie1@nhs.net
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, Prof.
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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