Clinical trial NCT05312554: Safety and Efficacy of IrisFIT™ Patent Foramen Ovale Occluders
Official title: A Prospective, Multi-Center, Single-Group Goal Value Clinical Trial to Revaluate the Safety and Efficacy of Patent Foramen Ovale Occluders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patent Foramen Ovale
Cryptogenic Stroke
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Technology (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 chest ultrasound (TTE) or esophageal ultrasound (TEE);
4. The presence of a large right-to-left shunt was confirmed by right aspiration angiography (cTTE or cTCD);
5. 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. intracardiac thrombosis or tumor, intracardiac neoplasm;
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: Accurate success rate
timeFrame: 6 month
Secondary outcomes:
measure: Success rate of occluder implantation technology
timeFrame: one week after surgery
measure: Success rate of occluder implantation
timeFrame: one week after surgery
measure: Success rate of complete occlusion
timeFrame: 180 days after surgery
measure: Effective plugging success rate
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: Kunming
country: China
facility: Fuwai Yunnan Cardiovascular Hospital
state: Yunnan
Study officials:
affiliation: Fuwai Yunnan Cardiovascular Hospital
name: Xiangbin Pan, Doctor
role: PRINCIPAL_INVESTIGATOR
References: