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.
1 other identifier
interventional
244
1 country
14
Brief Summary
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedStudy Start
First participant enrolled
June 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
ExpectedSeptember 1, 2023
August 1, 2023
1.9 years
February 26, 2023
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate of effective occlusion
Effective occlusion was defined as: 180 days after the surgery, Transthoracic echocardiography (TTE) showed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast transthoracic echocardiography (cTTE) showed no or only a small amount of right-to-left shunt, that is, no microvesicles or less than 10 microvesicles/frame in left heart cavity after Valsalva and resting state.
180 days after surgery
Secondary Outcomes (9)
Success rate of occluder implantation technology
7 days after surgery
Success rate of surgical implantation of occlusion
7 days after surgery
Success rate of complete occlusion
180 days after surgery
Success rate of effective occlusion
360 days after surgery
Recurrence or incidence of cryptogenic stroke during follow-up
360 days, 2 years, 3 years, 4 years, 5 years after surgery
- +4 more secondary outcomes
Study Arms (2)
Cera™ patent foramen ovale occluders
EXPERIMENTALPatients 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).
Another patent foramen ovale occluders
ACTIVE COMPARATORPatients 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).
Interventions
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).
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
You may qualify if:
- Patients aged 18-60 years;
- Be able to understand the purpose of the experiment, voluntarily participate in the experiment and sign the informed consent;
- Patent foramen ovale was confirmed by at least one of the following conditions exists:
- Patent foramen ovale was confirmed by Transthoracic echocardiography (TTE) or Transesophageal echocardiography (TEE);
- The presence of medium or large right-to-left shunt was confirmed by Right-heart acoustic contrast (cTTE or cTCD);
- It meets the clinical status of patent foramen ovale plugging indication, and at least one of the following conditions exists:
- Cryptogenic stroke complicated with patent foramen ovale, combined with one or more clinical risk factors;
- Cryptogenic stroke complicated with patent foramen ovale, combined with one or more anatomical risk factors of patent foramen ovale;
- Cryptogenic stroke complicated with patent foramen ovale, with clear deep vein thrombosis or pulmonary embolism, and not suitable for anticoagulant therapy;
- Cryptogenic stroke complicated with patent foramen ovale, but still recurred with antiplatelet or anticoagulant therapy.
You may not qualify if:
- Carotid atherosclerotic stenosis was determined by the investigator based on CT or vascular ultrasound (\> 50%);
- 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);
- Patients with intracardiac thrombosis or tumor, intracardiac vegetations;
- Acute myocardial infarction or unstable angina within 6 months;
- Left ventricular aneurysm formation or left ventricular wall movement disorder;
- 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;
- Dilated cardiomyopathy, LVEF \< 35%, or other severe heart failure;
- Patients with right-to-left shunt due to other causes, including atrial septal defect or perforated diaphragm;
- Atrial fibrillation/atrial flutter (chronic or intermittent);
- Pregnant or planning to become pregnant during the trial;
- Patients with active endocarditis or other untreated infections or other hemorrhagic diseases;
- Pulmonary hypertension or patent foramen ovale was a special channel;
- 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);
- Uncontrolled hypertension (\> 180/100 mmHg);
- Contraindication of antiplatelet or anticoagulant therapy, such as severe bleeding within 3 months, obvious retinopathy, history of other intracranial bleeding, and obvious intracranial diseases;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Fuwai Hospital ，CAMS&PUMC
Beijing, Beijing Municipality, 100037, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Meizhou people'Hospital
Meizhou, Guangdong, 514031, China
The Second XiangYa Hospital of Central South University
Changsha, Hunan, 410000, China
The Third XiangYa Hospital of Central South University
Changsha, Hunan, 410000, China
The First Hospital Of JiLin Universitv
Changchun, Jilin, 130021, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110015, China
Qilu Hospitalof Shandong University
Jinan, Shandong, 250012, China
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250014, China
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, 650000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangbin Pan, Doctor
Fuwai Yunnan Cardiovascular Hospital
Central Study Contacts
Hongbo Yang, Bachelor
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 17, 2023
Study Start
June 8, 2023
Primary Completion
April 30, 2025
Study Completion (Estimated)
June 30, 2029
Last Updated
September 1, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share