Evaluating Cera™ devices for closing heart openings in stroke patients

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

This study is testing a new device to see if it can safely close heart openings in stroke patients and work as well as other options available.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 244 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 14 sites (Beijing, Beijing Municipality and 13 other locations)
• Trial ID: NCT05774288 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of Cera™ patent foramen ovale occluders developed by Lifetech Scientific for patients experiencing cryptogenic stroke associated with a patent foramen ovale. It is a prospective, multi-center, randomized, controlled non-inferiority trial that requires strict adherence to the implant instructions. Participants will be monitored to determine the occluder's performance compared to other available devices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with confirmed patent foramen ovale and a history of cryptogenic stroke.

Not a fit: Patients outside the age range of 18-60 or those without a confirmed patent foramen ovale may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a new effective treatment option for patients with cryptogenic stroke linked to patent foramen ovale.

How similar studies have performed: Other studies have shown promise in using occluders for similar conditions, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients aged 18-60 years;
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:

1. Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\> 50%);
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.

Where this trial is running

Beijing, Beijing Municipality and 13 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fuwai Hospital ，CAMS&PUMC — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Meizhou people'Hospital — Meizhou, Guangdong, China (Recruiting)
• The Second XiangYa Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The Third XiangYa Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The First Hospital Of JiLin Universitv — Changchun, Jilin, China (Not_yet_recruiting)
• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Not_yet_recruiting)
• Qilu Hospitalof Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) — Jinan, Shandong, China (Not_yet_recruiting)
• Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xiangbin Pan, Doctor — Fuwai Yunnan Cardiovascular Hospital
• Study coordinator: Xiangbin Pan, Doctor

Conditions Patent Foramen Ovale; Cryptogenic Stroke