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.

Overview

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.

Interventions

• Device 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).
• Device 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).

Primary outcome measures

• Success rate of effective occlusion [Time frame: 180 days after surgery]

Secondary outcome measures (9)

• Success rate of occluder implantation technology [Time frame: 7 days after surgery]
• Success rate of surgical implantation of occlusion [Time frame: 7 days after surgery]
• Success rate of complete occlusion [Time frame: 180 days after surgery]
• Success rate of effective occlusion [Time frame: 360 days after surgery]
• Recurrence or incidence of cryptogenic stroke during follow-up [Time frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery]
• All-cause mortality rate [Time frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery]
• Incidence of new atrial fibrillation and atrial flutter during follow-up period [Time frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery]
• Incidence of device-related serious adverse events during follow-up (including device-related thrombosis, embolic stroke, and peripheral stroke) [Time frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery]
• Incidence of device defects. [Time frame: 360 days, 2 years, 3 years, 4 years, 5 years after surgery]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Coronary heart disease, hypertension, diabetes and other vascular diseases that are poorly controlled by drugs or other means;
• 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;
• Thrombosis exists at the location or route of implantation;
• Malignant neoplasms or other diseases with a life expectancy of less than 2 years;
• Patients who could not be followed up during the trial;
• Participate in clinical trials of other drugs or medical devices within three months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 14 centers

• Peking University First Hospital — Beijing
• Fuwai Hospital ，CAMS&PUMC — Beijing
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou
• Meizhou people'Hospital — Meizhou
• The Second XiangYa Hospital of Central South University — Changsha
• The Third XiangYa Hospital of Central South University — Changsha
• The First Hospital Of JiLin Universitv — Changchun
• General Hospital of Northern Theater Command — Shenyang
• … and 6 more centers

Identifiers

NCT: NCT05774288 · TB-CM01-P-275

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗