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RECRUITING
NCT04339699
NA

NobleStitch EL STITCH Trial is a PFO Comparative Trial

Sponsor: Nobles Medical Technologies II Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

NobleStitch™EL Suture Mediated Closure System

Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch™EL suture Medicate Closure System

DEVICE

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