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Clinical Trial Summary

STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitchâ„¢ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.


Clinical Trial Description

To demonstrate the non-inferiority of the NobleStitchâ„¢ 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 Design


Related Conditions & MeSH terms


NCT number NCT04339699
Study type Interventional
Source Nobles Medical Technologies II Inc
Contact
Status Suspended
Phase N/A
Start date January 1, 2021
Completion date June 30, 2027

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