STITCH - Prospective Multi Center Comparative Parallel Concurrent Study of the NobleStitch EL Compared to FDA Approved Amplatzer Occluder Device for Closure of Patent Foramen Ovale to Prevent Recurrent Ischemic Stroke
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female ages 18 - 60 years old
• A PFO and a Cryptogenic Stroke verified by a neurologist
• Stroke is 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 or CT findings of a new, neuroanatomical relevant infarct
• Cryptogenic stroke was defined as a stroke of unknown cause
• Prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required)
• Intra and extracranial artery imaging: Magnetic Resonance Angiography, CT angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (The aortic arch may also be evaluated by TEE).
• Hypercoagulable state assessment to rule out an underlying hypercoagulable state