NCT07356284招募中3 期
Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
ProMedica Health System1 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2026年5月19日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Presenting with symptoms consistent with AIS
- •Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling
- •Ability to randomize within 24 hours of stroke onset.
- •Pre-stroke mRS score 0-2
- •Ability to obtain signed informed consent.
- •ASPECTS Score ≥ 6 by non-contrast CT scan
- •Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT
- •If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.
- •For subjects presenting >6 hours from stroke onset, infarct core volume <50 cc quantified by CTP
排除标准
- •Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- •Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
- •CT evidence of the following conditions:
- •Midline shift or herniation
- •Evidence of intracranial hemorrhage
- •Mass effect with effacement of the ventricles
- •Acute bilateral strokes
- •Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
- •Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms
- •Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
- •Baseline platelet count <80,000 per microliter (µl)
- •Life expectancy less than one year prior to stroke onset
- •Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
- •Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
- •New diagnosis of atrial fibrillation or a history of atrial fibrillation
- •Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
- •Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis
研究组 & 干预措施
Randomized to Mechanical Thrombectomy (MT) plus adjunct Stenting
Experimental
Patients will have mechanical thrombectomy (MT) and stenting
干预措施: Mechanical Thrombectomy plus adjunct stenting (Procedure)
Randomized to Mechanical Thrombectomy (MT)
Active Comparator
Patients will only have mechanical thrombectomy (MT) done
干预措施: Mechanical Thrombectomy (Device)
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 90 (+/- 30) days post treatment
• Utility weighted 90-day Modified Rankin Score (mRS)
Primary Safety Endpoint
时间窗: 90 (+/- 30 ) days post treatment
Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12/+16 hours) from randomization)
次要结局
- Secondary Safety Endpoint(8 (+/- 3) days or Discharge post treatment)
- Secondary Safety Endpoint(Immediate post treatment)
- Secondary Safety Endpoint(1 year (+/- 60) days post treatment)
- Secondary Safety Endpoints(1 year (+/- 60) days post treatment)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Basilar Artery Occlusion Chinese Endovascular Registry in Patients With Large-Core InfarctNCT07345702Xuanwu Hospital, Beijing518
招募中
不适用
Access Sheath and Stent TrialKidney StoneNCT07297953University of Michigan184
尚未招募
不适用
IAT-MeVO Trial Domain Within the ACT-GLOBAL Adaptive Platform TrialNCT07336927Bo Wu614
尚未招募
不适用
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac RevascularizationNCT07304102W.L.Gore & Associates100
尚未招募
不适用
The Efficacy and Safety of Endovascular Therapy for Acute Ischemic Stroke Due to Large Core InfarctionNCT07333950Beijing Tiantan Hospital308