NCT04339699

NobleStitch EL STITCH Trial is a PFO Comparative Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 640 (estimated)
• Sponsor: Nobles Medical Technologies II Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Foramen Ovale, Patent
• Stroke, Ischemic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2020-04-09
• Last updated: 2026-03-23

Locations

2 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated device study