NCT07216170尚未招募不适用
REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
Microvention-Terumo, Inc.0 个研究点目标入组 200 人开始时间: 2026年12月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Incidence of all symptomatic intracranial hemorrhage (sICH)
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of the SOFIA Flow 88 Aspiration Catheter for treatment of acute ischemic stroke.
详细描述
The investigation is a prospective, single-arm, multi-center clinical study. The study will be conducted in up to 40 investigational sites in the US, Canada, and Europe. This study will enroll up to 200 subjects, with a maximum enrollment of 30 subjects per site.
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
- •Age ≥18 years on the date of consent
- •National Institutes of Health Stroke Score (NIHSS) ≥6
- •Alberta Stroke Program Early CT Score (ASPECTS) ≥6 assessed within 120 minutes before arterial access, defined by either baseline non-contrast computed tomography (NCCT) or baseline diffusion-weighted magnetic resonance imaging (DW-MRI)
- •Angiographically suitable for endovascular intervention and the interventionalist estimates that arterial access can be achieved within 8 hours from time last known well
- •Independent status immediately pre-stroke defined as ability to perform all activities of daily living as defined by mRS 0-1
- •Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 segment technically accessible, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter
- •Subject or legally authorized representative (LAR) is willing and able to provide informed consent, as evidenced by signing and dating the IRB-approved informed consent form prior to initiation of any study-specific procedures
- •Willing and able to comply with the protocol-specified procedures and assessments
排除标准
- •Any intracranial hemorrhage at baseline
- •Previous stroke within 90 days
- •Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- •Arterial occlusive lesion is not technically amenable to recanalization, as assessed during the index procedure, using a SOFIA Flow 88 Aspiration Catheter (e.g., an extracranial carotid lesion prevents access, evidence of carotid dissection)
- •Clinical symptoms or non-invasive imaging suggestive of or confirming bilateral stroke or stroke in multiple territories defined as multiple large vessel occlusions (e.g., bilateral proximal MCA occlusions)
- •Comorbid illness that would confound the neurological or functional evaluation or is severe enough (e.g., metastatic cancer, severe congestive heart failure) such that life expectancy is <1 year or the 90-day outcome is likely to be determined by the comorbid illness
- •Any contraindication to endovascular thrombectomy, such as a known history of severe contrast allergy or absolute contraindication to iodinated contrast
- •Participation in another clinical trial involving an investigational mechanical device (subjects may be co-enrolled in a registry study where there is no investigational treatment).
研究组 & 干预措施
SOFIA Flow 88 Aspiration Catheter
Experimental
干预措施: SOFIA Flow 88 Aspiration Catheter (Device)
结局指标
主要结局
Incidence of all symptomatic intracranial hemorrhage (sICH)
时间窗: 24 hours post-procedure
Reperfusion success
时间窗: During procedure
Defined as independent core laboratory adjudicated modified thrombolysis in cerebral infarction (mTICI)/expanded thrombolysis in cerebral infarction (eTICI) ≥2b flow, using the SOFIA Flow 88 Aspiration Catheter only within ≤ 3 passes and without additional intraprocedural mechanical thrombectomy devices or intra-arterial thrombolytic therapy.
次要结局
- Reperfusion success (defined as independent core laboratory adjudicated mTICI/eTICI ≥2b flow)(During procedure)
- Time from arterial access to achieve mTICI/eTICI ≥2b(During procedure)
- Incidence of mTICI/eTICI 3 reperfusion(During procedure)
- Incidence of mTICI/eTICI ≥2c reperfusion(During procedure)
- Incidence of mTICI/eTICI ≥2b reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter(During procedure)
- Incidence of mTICI/eTICI ≥2c reperfusion achieved with first pass of the SOFIA Flow 88 Aspiration Catheter(During procedure)
- Incidence of functional independence (modified Rankin scale (mRS) ≤2)(90-days follow-up)
- Mortality(90 days post-procedure)
- Incidence of intracranial hemorrhage (ICH)(24 hours post-procedure)
- Incidence of Embolization to New Territory(During procedure)
研究者
相似试验
已完成
不适用
Safety and Performance Study of Large Hole Vascular Closure DevicePercutaneous Closure of Arteriotomy in Common Femoral ArteryNCT01943344Vivasure Medical Limited12
已完成
2 期
Mechanical Recanalization With Flow Restoration in Acute Ischemic StrokeAcute StrokeNCT01210729Universität des Saarlandes40
已完成
不适用
The Optiflow Patency and Maturation StudyEnd-stage Kidney DiseaseEnd-stage Renal DiseaseNCT01921933Bioconnect Systems, Inc51
已完成
不适用
Safety and Performance Study of Large Hole Vascular Closure DevicePercutaneous Common Femoral Artery Arteriotomy ClosureNCT02241642Vivasure Medical Limited65
终止
3 期
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC SystemThe Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter RemovalNCT01597570Taewoong Medical Co., Ltd.52