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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
TMC HealthCare
Tucson, Arizona, United States
USF/Tampa General Hospital
Tampa, Florida, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Inova Structural Heart Disease Program - Fairfax
Fairfax, Virginia, United States
Effective PFO closure rate of the NobleStitch EL
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
Time frame: 6 months
Decreased event rate of recurrent ischemic stroke following PFO closure using NobleStitch EL
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
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale S. Eugenio
Rome, Lazio, Italy