Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 22
- 主要终点
- The Modified Rankin Scale Score
研究概览
简要总结
The purpose of this study is to compare the effectiveness of treating acute ischemic stroke with mechanical embolectomy using the Merci Retriever or the Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from mechanical embolectomy by the appearance of stroke on multimodal computerized tomography (CT) or magnetic resonance (MR) imaging.
详细描述
Stroke most commonly occurs when there is a blockage of blood flow to one of the arteries in the brain. The blockage is often caused by a clot. There is currently only one FDA-approved stroke treatment. However, only 2 percent of ischemic stroke patients receive this treatment because it must be given within 4.5 hours of the stroke onset. There is an overwhelming need for new treatments that extend the time window to treatment since most individuals with stroke arrive at the hospital after the 4.5-hour time window.
Two of the most promising new devices are the Merci Retriever, a tiny corkscrew device, and the Penumbra System, an aspiration device. Both are designed to remove clots from arteries and thereby restore blood flow to the brain.
The primary purpose of this study is to compare the effectiveness of treatment with the Merci Retriever or Penumbra System within 8 hours of symptom onset to standard medical treatment, and to identify people who might benefit from the devices by the appearance of the stroke on multimodal computerized tomography (CT) or magnetic resonance imaging (MRI). Previous testing has determined that the use of the Merci Retriever is successful in opening up blocked blood vessels in approximately ½ of the individuals in whom it is used, and the Penumbra System is successful in opening up blocked blood vessels in approximately 80% of the individuals in whom it is used.
A total of 120 participants from approximately 30 different medical centers will be enrolled into this study. Participants will be randomized to either receive treatment by mechanical embolectomy with the Merci Retriever or Penumbra System and standard medical care or treatment with standard medical care alone. Standard care for stroke patients may include intravenous fluid, careful regulation of blood pressure, blood-thinning medicine (such as heparin or warfarin), anti-platelet medicine (such as aspirin or clopidogrel), and rehabilitation therapies.
Participants undergoing the Merci Retriever or Penumbra System procedure will have a cerebral arteriogram with pictures taken with dye prior to the procedure to determine the location of the blockage, and following the procedure to determine if blood supply has been restored. The total mechanical embolectomy procedure with either device will take approximately 1 to 2 hours. Participants will have brief neurological exams several times during this time to monitor changes in their neurological condition.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6)
- •Age >/= 18 ≤ 85
- •Clot retrieval procedure can be initiated within 8 hours from onset
- •Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA)
- •Pretreatment MRI performed according to MR RESCUE protocol
- •Signed informed consent obtained from the patient or patient's legally authorized representative
- •Premorbid modified Rankin score of 0-2
- •Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion)
排除标准
- •NIHSS >/= 30
- •Contraindication to MRI (pacemaker etc)
- •Acute intracranial hemorrhage
- •Rapidly improving neurological signs prior to randomization
- •Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
- •Pregnancy
- •Known allergy to iodine previously refractory to pretreatment medications
- •Current participation in another experimental treatment protocol
- •Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection
- •INR > 3.0 (international normalized ratio)
- •PTT > 3 x Normal (partial thromboplastin time)
- •Imaging data cannot be processed by the MR RESCUE computer
- •Renal Failure (serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30)
- •MRI Exclusion Criteria:
- •Contraindication to MRI (pacemaker, etc)
- •CT Exclusion Criteria:
- •Contraindication to iodinated contrast**
- •**Examples of possible iodinated contrast contraindications include:
- •Hyperthyroidism
- •History of severe allergic reaction to iodinated contrast material
- •History of sever kidney disease as an adult, including tumor or transplant surgery, or family history of kidney failure
- •Paraproteinemia syndromes or multiple myeloma
- •Collagen vascular disease
- •Severe cardiac insufficiency
- •Severely compromised liver function
- •Current therapy with metformin, aminoglycosides
研究组 & 干预措施
2
standard medical care
1 Mechanical Embolectomy
Participants will be randomized to receive mechanical embolectomy treatment either with the Merci Retriever or Penumbra System and standard medical care or treatment with standard medical care alone.
干预措施: Merci Retriever and Penumbra System (Device)
结局指标
主要结局
The Modified Rankin Scale Score
时间窗: at 90 days post-stroke
Scale name is provided (Modified Rankin Scale) which is a standard measure of functional neurologic outcome in stroke. The scale runs from 0-6, running from perfect health without symptoms to death. * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.
次要结局
- Day 90 Mortality(at day 90)
- Symptomatic Hemorrhagic Transformation(from baseline to day 7)
研究者
Chelsea S. Kidwell, MD
Professor of Neurology
Georgetown University