Clinical Evaluation of Continuous Dual Aspiration Technique With Zoom System for Stroke (ADAPT 2.0)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 19
- 主要终点
- Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab
研究概览
简要总结
This study is designed to evaluate the effectiveness, safety and clinical performance of ADAPT 2.0, first-line aspiration neurothrombectomy with Zoom System with Continuous Dual Aspiration Technique (CDAT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥ 18 years of age
- •Subject or legally authorized representative has provided written informed consent prior to any study-specific procedures and no later than 72 hours after the index procedure
- •Pre-stroke mRS 0-2
- •Subject is undergoing or has undergone an aspiration thrombectomy using the Zoom System with Continuous Dual Aspiration Technique (CDAT) as the first line device within its intended use
排除标准
- •Subjects with a life expectancy of less than 6 months
- •Female subject who is known to be pregnant at time of admission
- •Any intracranial hemorrhage in the qualifying head CT or MRI
- •Presence of tandem internal carotid artery occlusion, multiple occlusion locations (e.g., cavernous ICA and M1, separate M2 occlusions, etc.), or occlusions in multiple territories (e.g., MCA and ACA, bilateral, etc.).
- •In the opinion of the Investigator, the patient is not a suitable candidate for intervention with the Zoom System
- •Subject is currently enrolled in or planned to be enrolled in any concurrent interventional study that may impact the safety or performance data collected in this study
研究组 & 干预措施
ADAPT 2.0: Zoom System with Continuous Dual Aspiration Technique (CDAT)
The Zoom System is intended to be used as the first-line device and utilized within the FDA-cleared indications for use, consistent with the approved labeling and intended anatomical targets.
干预措施: Zoom System (Device)
结局指标
主要结局
Proportion of patients achieving modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2c at the end of procedure, as adjudicated by independent core-lab
时间窗: End of procedure
mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion. mTICI 0: No antegrade reperfusion; mTICI 1: Antegrade reperfusion past initial occlusion, limited distal filling; mTICI 2a: Antegrade reperfusion of less than half (\<50%) of the previously occluded target artery's ischemic territory; mTICI 2b: Antegrade reperfusion of more than half (≥50%) of the previously occluded target artery's ischemic territory; mTICI 2c: Near-complete (90-99%) reperfusion, or filling of all distal branches with slower flow; mTICI 3: Complete antegrade reperfusion of all branches
Rate of Embolization to New Territory (ENT) on final angiography at the end of the procedure by investigator assessment
时间窗: End of procedure
Embolization to New Territory (ENT), defined as the presence of new occlusions on final angiography that occur in vascular territories remote from those effected by index stroke, as assessed by the investigator
次要结局
- Time to achieve mTICI≥2c, defined as groin puncture to investigator assessment for mTICI≥2c(Intraprocedural)
- Proportion of cases with clot ingestion, as evidenced by clot captured within the Zoom POD(Intraprocedural)
- Proportion of cases with clot captured within the Zoom POD connected to the outer aspiration catheter(Intraprocedural)
- Rate of rescue therapy(Intraprocedural)
- Rate of functional independence (mRS 0-2) at 90 days(90 days post-procedure)
- Proportion of patients achieving First Pass Effect (FPE) mTICI ≥2c as adjudicated by independent core-lab(Intraprocedural)
- Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging and independently adjudicated by medical monitor, at the 24-hour post-procedure(24-hour post-procedure)
- 90-day all-cause mortality(90 days post-procedure)
- Rate of device-related Serious Adverse Events, independently adjudicated medical monitor(Intraprocedural)