MedTrace Logo

Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders

NCT05312554 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-14

No results posted yet for this study

Summary

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

Conditions

  • Patent Foramen Ovale
  • Cryptogenic Stroke

Interventions

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)

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiangbin Pan, Doctor · Fuwai Yunnan Cardiovascular Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-12
Primary Completion
2023-12-25
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05312554 on ClinicalTrials.gov