Clinical Trials Logo

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


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

See also
  Status Clinical Trial Phase
Completed NCT00196040 - The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness N/A
Recruiting NCT01934725 - Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
Enrolling by invitation NCT03373929 - Stitch Closure of PFO and Septal Repair N/A
Completed NCT02432131 - Decompression Sickness in Divers With or Without Patent Foramen Ovale
Recruiting NCT04987008 - Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
Recruiting NCT04881578 - Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Completed NCT02400892 - Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries N/A
Recruiting NCT01385670 - InterSEPT: In‐Tunnel SeptRx European PFO Trial N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Completed NCT00968032 - Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System N/A
Completed NCT02127294 - Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine N/A
Recruiting NCT01149447 - Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale N/A
Recruiting NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder N/A
Recruiting NCT04339699 - NobleStitch EL STITCH Trial is a PFO Comparative Trial N/A
Withdrawn NCT03232450 - Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation N/A