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Stitch Closure of PFO and Septal Repair (STITCH)

Foramen Ovale, Patent Clinical Trial

Official title:
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System

Clinical Trial 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.

Clinical Trial Description

To demonstrate 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05025475
Study type Interventional
Source Nobles Medical Technologies II Inc
Contact
Status Enrolling by invitation
Phase N/A
Start date January 1, 2021
Completion date January 31, 2026
View Details
See also
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