A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 55
- 主要终点
- ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
研究概览
简要总结
The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.
详细描述
Each year 17 million people suffer stroke worldwide. According to the World Stroke Organization, stroke has become the second cause of death and disability worldwide. In the United States, every year, more than 795,000 people have a stroke. Given the large-scale challenges of curing stroke, prevention and treatments for stroke are much needed. Ischemic stroke is treatable in many patients if they have early access to viable treatments.
This trial is a prospective, multicenter, open-label, single-arm trial designed to assess the potential treatment benefits of using the Imperative Care 0.088" Catheters in conjunction with the other devices in the Zoom Reperfusion System to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Zoom Reperfusion System includes the Imperative Care 0.088" Catheters, the Zoom Reperfusion Catheters (0.035" to 0.071" Catheters), Zoom Aspiration Tubing, and Zoom Aspiration Pump. The trial will assess reperfusion success using the mTICI scores in the absence of any rescue therapy, reperfusion time, first-pass success, and functional independence including a quality-of-life assessment.
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
盲法说明
Reperfusion will be graded by an independent core lab that is not an enrolling investigational site.
Neurological Outcome Assessors (NIHSS assessment): Neurological outcome assessors who will perform post-procedure 24-hour NIHSS assessments are NIHSS certified team members not performing the thrombectomy procedure and with no financial conflict of interest with Imperative Care, Inc.
Functional Outcome Assessors (mRS assessment): Functional outcome assessors who will perform post-procedure assessments are part of achieving unbiased study objectives. They will not have access to patient data.
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
- •Age 18 and older
- •The operator feels that the stroke can be treated with endovascular thrombectomy approaches and the interventionalist estimates that groin puncture can be achieved within 8 hours from time last seen well
- •Pre-event mRS scale 0-1
- •Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidenced by MRA or CTA
- •For strokes in anterior circulation, ASPECTS >=6; For strokes in posterior circulation, pc-ASPECTS >=8
- •Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating stroke center or outside medical facility within 2 hours of treatment initiation
- •If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible
- •Consenting requirements met according to local IRB or Ethics Committee
排除标准
- •Female known to be pregnant at time of admission
- •Patient has suffered a stroke in the past 3 months
- •Presence of an existing or pre-existing large territory infarction
- •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor
- •Known history of severe contrast allergy or absolute contraindication to iodinated contrast
- •Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
- •Life expectancy of less than 6 months prior to stroke onset
- •Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
- •Subject participating in another clinical trial involving an investigational device or drug
- •Known cancer with metastases
- •Evidence of active systemic infection
- •Any known hemorrhagic or coagulation deficiency
- •Imaging Exclusion Criteria:
- •Evidence of intracranial hemorrhage on CT/MRI
- •CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access
- •Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088" ID Catheters
- •Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices
- •Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician
- •Significant mass effect with midline shift as confirmed on CT/MRI
- •Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI
- •Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis
结局指标
主要结局
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
时间窗: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
时间窗: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
时间窗: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
时间窗: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
时间窗: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
时间窗: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
次要结局
- ITT Cohort: Rate of mTICI Score 2c Reperfusion(Intraprocedural)
- ITT Cohort: Time to Achieve mTICI Score ≥ 2b(Intraprocedural)
- ITT Cohort: Rate of mTICI Score 3 Reperfusion(Intraprocedural)
- ITT Cohort: Rate of First Pass Success(Intraprocedural)
- ITT Cohort: Rate of Functional Independence(90-days post-procedure)
- ITT Cohort: Quality of Life Assessment(90 days post-procedure)
- ITT Cohort: Rate of All-Cause Mortality(90 days post-procedure)
- ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)(24-hour post-procedure)
- ITT Cohort: Rate of Embolization in New Territory (ENT)(24-hour post-procedure)
- ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)(90 days post-procedure)
- ITT Cohort: Rate of Serious Adverse Events(90 days post-procedure)
- FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b(Intraprocedural)
- FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion(Intraprocedural)
- FDA Clearance Cohort: Rate of First Pass Success(Intraprocedural)
- FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion(Intraprocedural)
- FDA Clearance Cohort: Rate of Functional Independence(90-days post-procedure)
- FDA Clearance Cohort: Quality of Life Assessment(90-days post-procedure)
- FDA Clearance Cohort: Rate of All-Cause Mortality(90-days post-procedure)
- FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)(24-hour post-procedure)
- FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)(End of procedure to 24-hour post-procedure)
- FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)(90-days post-procedure)
- FDA Clearance Cohort: Rate of Serious Adverse Events(90-days post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b(Intraprocedural)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion(Intraprocedural)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success(Intraprocedural)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion(Intraprocedural)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence(90-days post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment(90-days post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality(90-days post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)(24-hour post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)(End of procedure to 24-hour post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)(90-days post-procedure)
- FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events(90-days post-procedure)