Foramen Ovale, Patent, Stroke, Ischemic
Conditions
Keywords
Patent Foramen Ovale, Stroke
Brief summary
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.
Detailed description
To demonstrate the non-inferiority of the NobleStitch™ EL with medical management in both safety and effectiveness compared to the FDA-approved Amplatzer Occluder with medical management for PFO Closure. To demonstrate that the NobleStitch EL does not increase the incidence of ischemic stroke compared to published medical management data.
Interventions
DEVICENobleStitch™EL Suture Mediated Closure System
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
DEVICEAmplatzer PFO Occluder
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
Sponsors
Nobles Medical Technologies II Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A 640 participants indicated for percutaneous transcatheter closure of a PFO to reduce risk of recurrent Ischemic Stroke; between ages 18 - 60 years, who have had a Cryptogenic Stroke due to Paradoxical Embolism. To be conducted both in the USA and the European Union.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Female participant who is pregnant, lactating or planning a pregnancy during the course of the study * Age \<18 or \> 60 years of age * Previous myocardial infarction or unstable angina within 6 months * Clinically significant mitral or aortic valve stenosis or severe regurgitation * Left Ventricular Ejection Fraction \<50 percent * Progressive neurological dysfunction or reduced life expectancy * Contrast allergy * Atrial Septal Defect (baseline left to right shunt assessed by TEE or other congenital heart diseases * Active Endocarditis * Perspective participants with known causes of Ischemic Stroke * Arterial dissection * Contraindicated or unsuitable for antiplatelet agents or oral anticoagulants * Perspective participants with prosthetic heart valves * Uncontrolled diabetes Mellitus * Pulmonary hypertension * Uncontrolled systemic hypertension * Intracranial pathology * Neurological deficits not due to stroke that may affect neurologic assessments * Active autoimmune disease * Active infection * Alcohol and/or drug abuse * A requirement for chronic anticoagulation therapy that cannot be discontinued * Anatomic features (inability to achieve vascular access)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective PFO closure rate of the NobleStitch EL | 6 months | Effectiveness PFO closure rate of NobleStitch EL suture mediated closure with medical management compared to Amplatzer PFO occluder with medical management for PFO closure. Effective PFO closure rate defined as Grade 0 or 1 shunt at rest and during Valsalva at 6 month post closure attempts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL | 5 years | Safety of NobleStitch EL suture mediated closure system as compared to Amplatzer PFO Occluder Procedural and device related adverse event rate at 6 month follow up recurrent ischemic stroke through 5 years follow up |
Countries
Italy, United States
Contacts
CONTACTJames A Thompson, MD
CONTACTAnthony Nobles, Phd
STUDY_DIRECTORAnthony A Nobles, PhD
Nobles Medical Technologies II Inc
Outcome results
None listed