NCT05312554

Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

A Prospective, Multi-Center, Single-Group Goal Value Clinical Trial to Revaluate the Safety and Efficacy of Patent Foramen Ovale Occluders

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD

Detailed description

The purpose of this prospective, multi-center, single-group target value premarket clinical trial was to evaluate the safety and efficacy of a patent foramen ovale (PFO) occlator developed by Lifetech Technology (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.

Conditions

• Patent Foramen Ovale
• Cryptogenic Stroke

Interventions

Type	Name	Description
DEVICE	Iris FIT™ PFO closure system	Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Iris Patent foramen ovale occluder according to the INSTRUCTIONS for Use (IFU)

Timeline

• Start date: 2022-04-12
• Primary completion: 2023-12-25
• Completion: 2028-03-31
• First posted: 2022-04-05
• Last updated: 2023-03-14

Locations

1 site across 1 country: China