NobleStitch EL STITCH Trial is a PFO Comparative Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Foramen Ovale, Patent
- Stroke Ischemic
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A 640 participants indicated for percutaneous transcatheter closure of a PFO to reduce risk of recurrent Ischemic Stroke; between ages 18 - 60 years, who have had a Cryptogenic Stroke due to Paradoxical Embolism. To be conducted both in the USA and the European Union.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
Description
Prospective Multi Center Comparative parallel concurrent study of the NobleStitch EL as compared to the FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale (PFO) to prevent recurrent Ischemic Stroke.
Prospective Multi Center Comparative parallel concurrent study of the NobleStitch EL as compared to the FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale (PFO) to prevent recurrent Ischemic Stroke.
Tracking Information
- NCT #
- NCT04339699
- Collaborators
- Not Provided
- Investigators
- Study Director: Anthony A Nobles, PhD Nobles Medical Technologies II Inc
Get Well Soon