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Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

NCT05774288 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2023-09-01

No results posted yet for this study

Summary

To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;

Conditions

  • Patent Foramen Ovale
  • Cryptogenic Stroke

Interventions

DEVICE

Cera™ patent foramen ovale occluders

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).

DEVICE

Another patent foramen ovale occluders

Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with the Another patent foramen ovale occluders 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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2025-04-30
Completion
2029-06-30

Countries

  • China

Study Locations

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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 NCT05774288 on ClinicalTrials.gov