NCT06672510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)
Akura Medical29 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年1月27日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 118
- 试验地点
- 29
- 主要终点
- Effectiveness
研究概览
简要总结
This study is a prospective, single-arm, interventional, multicenter 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
- •Clinical signs, symptoms and presentation 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)
- •CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
- •Systolic BP ≥ 90 mmHg (initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
- •Stable HR < 130 BPM prior to the procedure
排除标准
- •Prior PE <180 days from index procedure
- •Thrombolytic use within 30 days prior to baseline CTA
- •Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 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 < 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 ≤ 6 months of enrollment
- •Cardiovascular or pulmonary surgery within the last 7 days
- •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 uncompensated 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 mechanical 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 (e.g., stage 4 cancer, frailty or severe COVID infections)
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study
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 (Device)
结局指标
主要结局
Effectiveness
时间窗: 48 hours
Change in RV/LV ratio from baseline
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 (29)
Loading locations...
相似试验
撤回
不适用
Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary EmbolismPulmonary Embolism AcuteNCT06362928Akura Medical15
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
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
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)Acute Ischemic StrokeNCT02964702JIMRO Co., Ltd.50
招募中
不适用
The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke PatientsAcute Ischemic StrokeStrokeNCT05667103Xuanwu Hospital, Beijing330
相关资讯
Akura Medical's Katana System Approved for Pivotal Pulmonary Embolism Trial- Akura Medical received FDA IDE approval for the QUADRA-PE trial to evaluate the Katana Thrombectomy System in acute pulmonary embolism patients.
- The QUADRA-PE study is a multi-center, international trial aiming to enroll up to 118 patients across 26 global sites.
- The Katana System features a bi-directional sheath, high-velocity saline jets, and real-time pulmonary artery pressure sensors for effective clot removal.
- Pulmonary embolism is a life-threatening condition affecting approximately 900,000 Americans annually, with a high mortality rate.last yearAkura Medical's Katana Thrombectomy System to Undergo Pivotal US Trial for Pulmonary Embolism Following FDA Approval- Akura Medical received FDA IDE approval to begin the QUADRA-PE trial, which will assess the Katana Thrombectomy System's safety and efficacy in acute pulmonary embolism.
- The Katana System features a bi-directional sheath, high-velocity saline jets, and real-time pressure sensors for improved clot removal and procedural feedback.
- The QUADRA-PE study is a multi-center, international trial enrolling up to 118 patients, with primary endpoints focusing on RV/LV ratio reduction and major adverse events.
- Pulmonary embolism is a life-threatening condition affecting approximately 900,000 Americans annually, highlighting the need for improved treatment options.last year