Status:
WITHDRAWN
Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Patent Foramen Ovale
Cryptogenic Stroke
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
To evaluate the performance of patent foramen ovale (PFO) device developed by Lifetech Technology (Shenzhen) Co., LTD
Detailed Description
The purpose of this prospective, multi-center, single-group target value premarket clinical trial was to evaluate the safety and efficacy of a patent foramen ovale (PFO) occlator developed by Lifetech...
Eligibility Criteria
Inclusion
- 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 chest ultrasound (TTE) or esophageal ultrasound (TEE);
- The presence of a large right-to-left shunt was confirmed by right aspiration angiography (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
- 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);
- intracardiac thrombosis or tumor, intracardiac neoplasm;
- 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.
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05312554
Start Date
April 12 2022
End Date
March 31 2028
Last Update
March 14 2023
Active Locations (1)
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1
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China