RecruitingNot ApplicableNCT05774288

Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

244 participants

Start Date

Jun 8, 2023

Study Type

INTERVENTIONAL

Conditions

Cryptogenic Stroke Patent foramen ovale

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Another patent foramen ovale occluders and a medical device called Cera™ patent foramen ovale occluders for people with cryptogenic stroke and patent foramen ovale. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECera™ 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).

DEVICEAnother 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).

Locations(14)

Peking University First Hospital

Beijing, Beijing Municipality, China

Fuwai Hospital ，CAMS&PUMC

Beijing, Beijing Municipality, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Meizhou people'Hospital

Meizhou, Guangdong, China

The Second XiangYa Hospital of Central South University

Changsha, Hunan, China

The Third XiangYa Hospital of Central South University

Changsha, Hunan, China

The First Hospital Of JiLin Universitv

Changchun, Jilin, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Qilu Hospitalof Shandong University

Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

Jinan, Shandong, China

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT05774288

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