NCT05152524已完成不适用
Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever
Rapid Medical20 个研究点 分布在 4 个国家目标入组 149 人开始时间: 2022年3月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 20
- 主要终点
- Successful reperfusion (CTP or MR PWI*) without sICH**.
研究概览
简要总结
The objective of the DISTALS Study is to evaluate the safety and effectiveness of the Tigertriever 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in patients presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old.
- •Pre-stroke mRS ≤
- •Disabling presenting deficits that localize to the territory of the distal vessel occlusion. Disabling deficits are deficits that, if unchanged, would prevent the subject from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work.
- •NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.
- •Perfusion lesion (Tmax >4.0 seconds) volume ≥10 cc on CTP or MR PWI within the territory of the anterior cerebral artery (ACA) segments, a non-dominant or co-dominant M2 middle cerebral artery (MCA) segment, an M3 MCA, or the posterior cerebral artery (PCA) segments.
- •Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.
- •Ischemic core lesion (rCBF<30% on CTP or ADC <620 on MR DWI) in ≤50% of the perfusion lesion volume.
- •Study treatment can be initiated within 24 hours of last known well time (last known time without current stroke symptoms).
- •Signed informed consent by patient or legally authorized representative.
- •Subject is not eligible for intravenous thrombolysis within 3 hours from stroke onset per FDA label and American Heart Association/American Stroke Association national guidelines. (Note: administration of intravenous thrombolytics should not be avoided or delayed in order to achieve participation in this study.)
排除标准
- •Evidence of acute brain hemorrhage on CT and/or MRI at admission.
- •Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
- •The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
- •Excessive tortuosity or stenosis that is anticipated to prevent placement of the microcatheter in the target vessel. Tortuosity or stenosis will be determined on CTA or MRA prior to randomization.
- •Evidence of tandem occlusion in the cervical internal carotid artery (ICA), intracranial ICA, M1 MCA, dominant M2 MCA, vertebral artery (VA) or basilar artery (BA) on CTA or MRA.
- •Evidence of dissection in the extra or intracranial cerebral arteries.
- •Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
- •Prior stroke in the last 3 months.
- •Anticipated inability to obtain 3-month follow-up assessments.
- •Females who are pregnant or breastfeeding.
- •Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <
- •Pre-procedural severe sustained hypertension with SBP >220 and/or DBP >
- •Pre-procedural glucose <50 mg/dl (2.78 mmol/L) or >400 mg/dl (22.20 mmol/L).
- •Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.
- •Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
- •Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
- •Platelet count of less than 50,000/uL.
- •History of severe allergy to contrast medium, nickel, or Nitinol.
- •Known current use of cocaine at time of treatment.
- •Known or suspected cerebral vasculitis.
- •Known hemorrhagic diathesis.
- •Aneurysm in target vessel.
- •Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
- •Ongoing seizure due to stroke.
- •Evidence of active systemic infection.
- •Known cancer with metastases.
- •Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- •Subject already participating in another study of an investigational treatment device or treatment.
研究组 & 干预措施
Treatment
Experimental
Mechanical thrombectomy with Tigertriever 13 EVT + MM (without thrombolysis).
干预措施: Tigertriever 13 (Device)
Control
No Intervention
Medical Management alone (without thrombolysis).
结局指标
主要结局
Successful reperfusion (CTP or MR PWI*) without sICH**.
时间窗: 24±6 Hours post randomization
\*Successful reperfusion is defined as \>50% reduction in substantial hypoperfusion (Tmax \>4 seconds) volume between baseline and 24 ±6 hours of randomization. \*\*sICH shall be defined as any parenchymal hematoma type 2, remote intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage that is the predominant cause of ≥4 point NIHSS deterioration at 24 ±6 hours of randomization.
次要结局
- All cause mortality at 90 days.(90 days post randomization.)
- Successful reperfusion (eTICI ≥2b50) rate in the distal occluded vessel after Tigertriever 13 mechanical thrombectomy (assessed in Treatment arm only).(24±6 hours Post procedure)
- modified Rankin Scale (mRS) score(90 days post randomization)
- Any asymptomatic intracranial hemorrhage within 24±6 hours of randomization.(24±6 hours of randomization.)
- Successful reperfusion at 24 hours, defined as >50% reduction in substantial hypoperfusion (Tmax >4 seconds) volume between baseline and 24 ±6 hours of randomization (assessed in both Treatment and Control arms).(24±6 hours post randomization)
- National Institutes of Health Stroke Scale (NIHSS) shift(4 days post procedure)
- EQ-5D score(90 days post randomization)
- Unanticipated adverse device effect (UADEs).(During procedure)
- Volume of penumbral tissue salvaged at 24±6 hours of randomization (CTP or MR DWI/PWI).(24±6 hours post randomization.)
- Device/procedure related serious adverse events (SAEs).(90 days post randomization.)
- MoCA: Montreal Cognitive Assessment(90 days post randomization)
研究者
研究点 (20)
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