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
Nobles Medical Technologies II Inc
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.
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- 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…
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
Locations (2)
- TMC HealthCareTucson, Arizona
- Ospedale S. EugenioRome, Lazio