NCT06697314招募中不适用
Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Reduction in RV/LV ratio
研究概览
简要总结
To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery
- •RV/LV diameter ratio ≥ 1.0 assessed by CTPA
- •Serum troponin levels above upper limit of normal as per hospital policy
- •≥ 18 years of age
- •At least one of the following:
- •Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
- •Systolic blood pressure ≤ 110mmHg for at least 15 minutes
- •Respiratory rate > 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air
- •Known history of heart failure
- •Willing and able to provide written informed consent prior to receiving study specific procedures.
排除标准
- •A contraindication to therapeutic anticoagulation
- •Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer)
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale >12
- •Indication for ECMO
- •Pregnant or breastfeeding
- •Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
- •Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.
- •History of congenital or acquired bleeding disorder predisposing to hemorrhagic state
- •Platelet count < 100,000/μL
- •Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention)
- •A known clot in transit
- •IVC filter
- •A do not resuscitate limitation at inclusion in the study
- •Deprived of liberty or under court protection
结局指标
主要结局
Reduction in RV/LV ratio
时间窗: 48 hours
Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA)
Incidence of Adverse Events [Safety and Tolerability]
时间窗: 12 months
The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented.
次要结局
- PE-related readmission(12 months)
- Symptom burden exercise test(12 months)
- Symptom burden classification(12 months)
- Functional outcome review(12 months)
- Symptomatic PE recurrence(30 days)
- CTEPH Diagnosis(12 months)
- Use of thrombolytics(48 hours)
- Change in Biomarkers(48 hours)
- Composite Major Adverse Events(7 days)
- Individual Major Adverse Events(7 days)
- Days in ITU(7 days)
- All-cause mortality(30 days)
- PE-related mortality(30 days)
- Device-related Serious Adverse Events(30 days)
- Hospital readmission(30 days)
- Reduction in clot burden(48 hours)
- Change in Biomarkers(48 hours)
- Days in ITU(7 days)
- All-cause mortality(30 days)
- Use of thrombolytics(48 hours)
- Composite Major Adverse Events(7 days)
- Device-related Serious Adverse Events(30 days)
- Hospital readmission(30 days)
- Symptom burden exercise test(12 months)
- Symptom burden classification(12 months)
- Individual Major Adverse Events(7 days)
- PE-related mortality(30 days)
- Days In-patient(30 days)
- Functional outcome review(12 months)
- Symptomatic PE recurrence(30 days)
- CTEPH Diagnosis(12 months)
- PE-related readmission(12 months)
研究者
研究点 (1)
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