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NobleStitch EL STITCH Trial is a PFO Comparative Trial
Sponsor: 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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2021-01-01
Completion Date
2027-06-30
Last Updated
2026-03-23
Healthy Volunteers
No
Conditions
Interventions
NobleStitch™EL Suture Mediated Closure System
Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System
Amplatzer PFO Occluder
Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
Locations (2)
TMC HealthCare
Tucson, Arizona, United States
Ospedale S. Eugenio
Rome, Lazio, Italy