Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
NCT ID: NCT05774288
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
244 participants
INTERVENTIONAL
2023-06-08
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cera™ patent foramen ovale occluders
Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Cera™ patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
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).
Another patent foramen ovale occluders
Patients with cryptogenic stroke complicated with patent foramen ovale will be implanted with the Another patent foramen ovale occluders according to the INSTRUCTIONS for Use (IFU).
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).
Interventions
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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).
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).
Eligibility Criteria
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Inclusion Criteria
2. Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
3. Patent foramen ovale was confirmed by at least one of the following conditions exists:
1. Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);
2. The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);
4. It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:
1. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
2. Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
3. Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
4. Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.
Exclusion Criteria
2. Large cerebral infarction occurred within 4 weeks (MR/CT or DWI image ASPECTS score \<6 points or infarction volume ≥70 ml or infarction area \> 1/3 middle cerebral artery blood supply area);
3. Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
4. Acute myocardial infarction or unstable angina within 6 months;
5. Left ventricular aneurysm formation or left ventricular wall movement disorder;
6. Mitral/aortic disease: including mitral stenosis or severe mitral regurgitation of any cause, severe aortic stenosis or severe aortic regurgitation, mitral or aortic valve vegetations or prior valve replacement surgery;
7. Dilated cardiomyopathy, LVEF \< 35%, or other severe heart failure;
8. Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
9. Atrial fibrillation/atrial flutter (chronic or intermittent);
10. Pregnant or planning to become pregnant during the trial;
11. Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
12. Pulmonary hypertension or patent foramen ovale was a special channel;
13. Liver and kidney function impairment (ALT or AST \> 3 times the upper limit of normal value, serum creatinine (Cr) \> 2 times the upper limit of normal value);
14. Uncontrolled hypertension (\> 180/100 mmHg);
15. Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
16. Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
17. The investigator determined that the patient was not suitable for implantation of PFO occluder (for example, the diameter of the base of the atrial septal tumor ≥25mm and the size of the foramen ovale ≥5mm) or the patient has contraindications for implantation of PFO occluder;
18. Thrombosis exists at the location or route of implantation;
19. Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
20. Patients who could not be followed up during the trial;
21. Participate in clinical trials of other drugs or medical devices within three months.
18 Years
60 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiangbin Pan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fuwai Yunnan Cardiovascular Hospital
Locations
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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
Countries
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Central Contacts
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Hongbo Yang, Bachelor
Role: CONTACT
Facility Contacts
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Yan Liang
Role: primary
Hanlu LI
Role: primary
Lei Tang
Role: primary
Fayou Yang
Role: primary
Chuankun Miao
Role: primary
Yuxia Xiang
Role: primary
Fei Wang
Role: primary
Hongying Zhang
Role: primary
Bailu Wang
Role: primary
Juan Yin
Role: primary
Da Zhu
Role: primary
Can Wang
Role: primary
Qingya Yang
Role: primary
Huafang Chen
Role: primary
Other Identifiers
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TB-CM01-P-275
Identifier Type: -
Identifier Source: org_study_id
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