NCT07300358尚未招募不适用
BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study
Shanghai Lingsi Medical Technology Co., Ltd.0 个研究点目标入组 258 人开始时间: 2025年12月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 258
- 主要终点
- Success rate of effective occlusion
研究概览
简要总结
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
详细描述
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical study. The study aims to evaluate the safety and efficacy of a novel biodegradable patent foramen ovale (PFO) occluder system compared to a conventional metallic occluder in patients with a PFO that is clinically determined to be associated with an PFO⁃associated stroke（PFO-AS）or transient ischemic attack (TIA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 65 years.
- •Presence of a patent foramen ovale (PFO) confirmed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
- •Presence of a moderate-to-large right-to-left shunt (RLS) at rest or during the Valsalva maneuver, as confirmed by agitated saline contrast echocardiography (also known as bubble study).
- •Clinically diagnosed with a PFO-associated ischemic stroke or transient ischemic attack (TIA).
排除标准
- •An alternative, clearly identified cause of ischemic stroke or TIA (other than PFO) is determined by the investigator.
- •Large territory cerebral infarction within 4 weeks prior to the planned procedure.
- •Atherosclerotic stenosis (>50%) of the carotid or vertebral arteries, as confirmed by CT angiography or vascular ultrasound per investigator assessment.
- •Presence of intracardiac thrombus or vegetation as confirmed by echocardiography.
- •Left ventricular ejection fraction (LVEF) < 35%.
- •Atrial fibrillation or atrial flutter.
- •Left ventricular aneurysm or severe regional wall motion abnormality.
- •Significant valvular stenosis or regurgitation, or history of valvular replacement or repair surgery.
- •Pulmonary hypertension or a PFO constituting a special conduit (e.g., right-to-left shunt due to elevated right heart pressures).
- •Other confirmed causes of right-to-left shunt, such as atrial septal defect (ASD) or pulmonary arteriovenous fistula.
- •Complex PFO anatomy (e.g., multi-tunnel PFO) or PFO associated with an ASD requiring different closure strategy.
- •Thrombus, mass, or vegetation identified at the intended implant site or along the potential delivery pathway.
- •Acute myocardial infarction or unstable angina within 3 months prior to the procedure.
- •Previous implantation of an inferior vena cava filter, PFO closure device, or ASD closure device.
- •Any other condition deemed by the investigator to make the patient unsuitable for PFO device implantation.
- •Concomitant cardiac anomalies requiring surgical correction.
- •Uncontrolled systemic or local infection, or sepsis.
- •Active infection requiring concurrent antibiotic therapy (Patients with transient conditions may be enrolled after completing antibiotic therapy and a subsequent 14-day washout period).
- •Contraindication to antiplatelet or anticoagulant therapy (e.g., major bleeding within 3 months, known retinopathy, history of intracranial hemorrhage, or other significant intracranial pathology).
- •Known hypersensitivity or allergy to tantalum or nickel.
- •Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.
- •Life expectancy less than 1 year due to malignancy or other comorbid disease.
- •Current participation in another investigational drug or device clinical study that has not yet completed its primary endpoint.
结局指标
主要结局
Success rate of effective occlusion
时间窗: at 12 months post-implantation
Effective occlusion was defined as: 12 months after the procedure, Echocardiographyshowed that the position and shape of the occluder were normal, and no horizontal atrial shunt was observed. Re-examination by Contrast echocardiography (cTTE or cTEE) 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.
次要结局
- Success rate of effective occlusion(at 6 months post-implantation)
- Device Success Rate(immediately after the procedure)
- Procedural success Rate(at discharge or 7 days post-procedure)
- Recurrence or incidence of cryptogenic stroke or TIA(From attempted procedure up to 12 months post-implantation)
- All-cause mortality(From attempted procedure up to 12 months post-implantation)
- Incidence of new atrial fibrillation and atrial flutter(From attempted procedure up to 12 months post-implantation)
- Incidence of device-related serious adverse events(From attempted procedure up to 12 months post-implantation)
- Device defects(From attempted procedure up to 12 months post-implantation)
- Migraine Headache events(At 6 months and 12 months post-implantation)
研究者
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