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NobleStitch EL STITCH Trial is a PFO Comparative Trial — STITCH  

Stroke, Ischemic Clinical Trial

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

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 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
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
View Details
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