NCT06362928撤回不适用
Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism
Akura Medical1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年2月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effectiveness
研究概览
简要总结
This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is > 18 and < 90 years old
- •Clinical signs and symptoms consistent with acute PE
- •PE symptom duration ≤ 14 days
- •CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator)
- •CTA evidence of RV/LV ratio > 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline;
- •Systolic BP ≥ 90 mmHg note: initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation
- •Stable heart rate (HR) < 130 BPM prior to procedure
- •Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment.
- •Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
排除标准
- •Prior PE < 180 days from index procedure
- •Thrombolytic use < 48 hours prior to baseline CTA
- •Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
- •Vasopressor requirement after fluids to keep pressure at ≥90 mmHg
- •FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
- •Hematocrit <28% (Note: hematocrit required within 6 hrs. of index procedure)
- •Platelets count <100,000/µL
- •eGFR <30 ml/min per 1.73 m2
- •International normalized ratio (INR) >3
- •Major trauma injury severity score (ISS) > 15
- •Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
- •Cardiovascular or pulmonary surgery within 7 days of index procedure
- •Actively progressing cancer treated by chemotherapeutics
- •Known bleeding diathesis or coagulation disorder
- •Left bundle branch block
- •History of severe or chronic pulmonary arterial hypertension
- •History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- •History of decompensated heart failure
- •History of underlying lung disease that is oxygen dependent
- •History of chest irradiation
- •History of heparin-induced thrombocytopenia (HIT)
- •Contraindication to systemic or therapeutic doses of anticoagulants
- •Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- •Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle).
- •CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus)
- •Life expectancy <90 days, as determined by investigator
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study Note: observational or registry studies may be permitted with Sponsor approval
研究组 & 干预措施
Patients with Acute Pulmonary Embolism
Experimental
Patients undergoing mechanical thrombectomy for acute pulmonary embolism.
干预措施: ATC System (Device)
结局指标
主要结局
Effectiveness
时间窗: 48 hours
Change in RV/LV ratio post index procedure
Safety: Composite of Major Adverse Device-Related Events
时间窗: 48 hours post index procedure
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
次要结局
- Safety: Composite of Major Adverse Events(30 days post index procedure)
研究者
研究点 (1)
Loading locations...
相似试验
暂停
不适用
Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)NCT06672510Akura Medical118
招募中
不适用
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel CatheterAcute Ischemic Stroke From Large Vessel OcclusionNCT06370182Anaconda Biomed S.L.327
已完成
不适用
A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration CatheterAcute Ischemic StrokeNCT05119647Zhuhai Tonbridge Medical Tech. Co., Ltd.124
已完成
不适用
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)Acute Ischemic StrokeNCT02964702JIMRO Co., Ltd.50
已完成
不适用
Solitaire FR Thrombectomy for Acute RevascularisationStroke, AcuteNCT01327989Medtronic Neurovascular Clinical Affairs202