Clinical trial NCT05774288: Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Official title: A Prospective, Multi-center, Randomized, Controlled Non-inferiority Clinical Trial to Evaluate the Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patent Foramen Ovale
Cryptogenic Stroke
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized controlled clinical trial
Primary purpose: TREATMENT

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

Detailed description: The purpose of this prospective, multi-center, randomized, controlled non-inferiority clinical trial was to evaluate the safety and efficacy of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD for the treatment of cryptogenic stroke complicated with patent foramen ovale. The study required the implant to follow instructions strictly.

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.

Primary outcomes:
measure: Success rate of effective occlusion
timeFrame: 180 days after surgery
Secondary outcomes:
measure: Success rate of occluder implantation technology
timeFrame: 7 days after surgery
measure: Success rate of surgical implantation of occlusion
timeFrame: 7 days after surgery
measure: Success rate of complete occlusion
timeFrame: 180 days after surgery
measure: Success rate of effective occlusion
timeFrame: 360 days after surgery
measure: Recurrence or incidence of cryptogenic stroke during follow-up
timeFrame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
measure: All-cause mortality rate
timeFrame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
measure: Incidence of new atrial fibrillation and atrial flutter during follow-up period
timeFrame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
measure: Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke)
timeFrame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
measure: Incidence of device defects.
timeFrame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: BeiJing
country: China
facility: Fuwai Hospital ，CAMS&PUMC
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Meizhou
country: China
facility: Meizhou people'Hospital
state: Guangdong
city: Changsha
country: China
facility: The Second XiangYa Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third XiangYa Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: The First Hospital Of JiLin Universitv
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: JInan
country: China
facility: Qilu Hospitalof Shandong University
state: Shandong
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
state: Shandong
city: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Fuwai Yunnan Cardiovascular Hospital
name: Xiangbin Pan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: