The purpose of this clinical study is the assessment of the safety and effectiveness of the Flex II PFO Occluder in the treatment of subjects 18 years of age or older who have had a cryptogenic stroke due to a presumed paradoxical embolism as…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effective Closure rates of the PFO, where effective PFO closure is defined as <=
25 bubbles demonstrated by TTE and bubble study at 12-month follow-up.
Secondary outcome
Non-fatal recurrent stroke through 12-month follow-up, which is defined as:
1. An acute focal neurological deficit presumed due to focal ischemia and
either:
2. persisting over 24 hours, or persisting for less than 24 hours but
associated with a new cerebral infarct documented with MRI or CT
Background summary
The rationale for conducting this investigation is that the safety and
effectiveness of PFO Closure to reduce the risk of recurrent ischemic stroke
has been established in two prospective randomized controlled clinical
investigations when compared to medical therapy alone. The Flex II PFO
Occluder is similar in design to the approved occluders, therefore, a
randomized study comparing the Flex II PFO Occluder investigational device to
approved PFO devices is appropriate.
Study objective
The purpose of this clinical study is the assessment of the safety and
effectiveness of the Flex II PFO Occluder in the treatment of subjects 18 years
of age or older who have had a cryptogenic stroke due to a presumed paradoxical
embolism as determined by a neurologist and cardiologist following an
evaluation to exclude known causes of ischemic stroke, and the presence of a
PFO determined by echocardiography.
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 SAEs
Study design
The OCCLUFLEX PFO Study is a randomized prospective, multi-center global study
comparing the clinical outcomes of the Flex II PFO Occluder to the standard of
care PFO Occlusion devices, which includes the Amplatzer PFO Occluder and the
Gore Cardioform PFO Occluder. Randomization will be 1:1 and will occur within
5 workingdays of the implant procedure.
The total duration of the study is expected to be 5 years (60 months).
The clinical study will be conducted in approximately 60 centers in the US,
Canada, and Europe.
Up to 450 subjects will be enrolled in this study.
Subjects will be followed up for 12 months for endpoint analysis and then
yearly up to 5 years post implant. Upon PMA approval subjects will be rolled
into a post approval study up to 5 years post implant.
Intervention
The following investigational devices will be used for the OCCLUFLEX PFO Study:
• Flex II PFO Occluder
• Occlutech Pistol Pusher delivery system
The following market released devices and delivery systems will be used for the
study:
• Amplatzer PFO Occluder
• Amplatzer Torqvue Delivery System
• Gore Cardioform PFO Occluder and Delivery System
• Cook Sheath
• Occlutech Delivery Set
Randomization will be 1:1 and will occur within 5 workdays of the implant
procedure.
Study burden and risks
Though the PFO procedure has risks associated with the study device and the
comparator devices, there are no extra risk that are directly related to the
study as all devices (study and comparators) are all approved for use on the
market and they will be used within the intended purpose.
Risk / adverse events associated with the study device and comparators are
listed in section 5 of the protocol.
9325 Upland Lane North Suite 315
Maple Grove MN 55369
US
9325 Upland Lane North Suite 315
Maple Grove MN 55369
US
Listed location countries
Age
Inclusion criteria
Subjects with a PFO and cryptogenic stroke:
• PFO defined as visualization of microbubbles (during 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:
o Symptoms persisting >=24 hours, or
o Symptoms persisting <24 hours with MR or CT findings of a new,
neuroanatomically relevant, cerebral infarct.
Exclusion criteria
General:
• Age <18 years
• MI or unstable angina within 6 months
• Mitral or aortic valve stenosis or severe regurgitation
• 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)
• 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 ASD or a fenestrated atrial
septum)
• Presence of an arterial hypercoagulable state:
o Lupus anticoagulant,
o anticardiolipin Abs,
o hyperhomocysteinemia,
o 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:
o A history of hypertension (except in the first week post stroke)
o A history of diabetes mellitus
o Age >=50 years
o 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 05069558 |
| CCMO | NL81852.078.22 |