FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
2026年8月5日 更新者：Penumbra Inc.
The objective of this study is to collect safety and effectiveness data on the Penumbra System reperfusion catheters in participants with isolated primary non-dominant and distal M2 occlusions who undergo endovascular mechanical thrombectomy (EVT).
Additionally, this study aims to observe characteristics and outcomes of participants treated with medical management (MM) alone and those who receive EVT + MM per current medical practice.
研究概览
详细说明
FORWARD is a prospective, multicenter, observational study that will be conducted internationally.
Participants who satisfy all inclusion criteria and none of the exclusion criteria will be eligible for enrollment. They will receive treatment according to the physicians' clinical judgement per standard of care at their institution.
研究类型
观察性的
注册 (估计的)
250
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Madeline Turtle
- 电话号码：260-224-8231
- 邮箱：MTurtle@PENUMBRAINC.COM
研究联系人备份
- 姓名：Jennifer Jelf
- 电话号码：510-440-5719
- 邮箱：jjelf@penumbrainc.com
学习地点
-
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Tennessee
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Knoxville、Tennessee、美国、37916
- 招聘中
- Fort Sanders Regional Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Participants experiencing acute ischemic stroke (AIS) due to a primary M2 occlusion in the vertical segment or post-bifurcation in the non-dominant or co-dominant branch of the horizontal segment.
描述
Inclusion Criteria:
- Participant age ≥ 18
- Participant experiencing acute ischemic stroke due to a confirmed primary M2 occlusion in the vertical segment or post-bifurcation in the non-dominant or co-dominant branch of the horizontal segment
- NIHSS ≥5 or NIHSS 3-4 with disabling symptoms
- Pre-stroke mRS 0-1
- For participants undergoing thrombectomy: Planned first-line treatment with Penumbra System reperfusion catheters
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria:
- Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period.
- Known multiple occlusions
- Secondary M2 occlusion
- Known or high suspicion of underlying ICAD as the cause of the M2 occlusion
- Current hospitalization at time of stroke onset and/or any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment. Participants in secondary prevention, observational, natural history and/or epidemiological studies are eligible.
- Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Medical Management
|
All medical management treatment will follow established guidelines for the care of stroke patients.
All medical treatments and supportive care will be administered following each participating hospital's routine practice and in accordance with the Instructions for Use for any medication administered.
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Endovascular Thrombectomy plus Medical Management
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All medical management treatment will follow established guidelines for the care of stroke patients.
All medical treatments and supportive care will be administered following each participating hospital's routine practice and in accordance with the Instructions for Use for any medication administered.
Patients will undergo endovascular thrombectomy plus medical management.
Patients will be treated with the Penumbra System Reperfusion Catheters.
Perioperative and postoperative management will follow established guidelines for the care of stroke patients.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in NIHSS at 24 hours
大体时间：24 hours
|
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination tool used to measure the severity of a stroke.
The scale ranges from 0 to 42, with higher scores indicating greater impairment.
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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90-day Modified Rankin Scale (mRS)
大体时间：90 Days
|
The modified Rankin Scale (mRS) is used to measure the degree of disability or dependence in daily activities in people who have experienced a stroke.
Scores range from no symptoms (0) to death (6), with higher scores indicating greater severity.
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90 Days
|
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Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment
大体时间：Treatment/Procedure
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Treatment/Procedure
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90-day NIHSS
大体时间：90 Days
|
The National Institutes of Health Stroke Scale (NIHSS) is a standardized neurological examination tool used to measure the severity of a stroke.
The scale ranges from 0 to 42, with higher scores indicating greater impairment.
|
90 Days
|
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Quality of Life, as measured by Barthel Index
大体时间：90 Days
|
The Barthel Index is a 0-100 point scale used to measure a person's functional independence in daily activities.
The index rates 10 items, including feeding, bathing, grooming, dressing, bowel/bladder control, toilet use, transfers, mobility, and stair use.
Higher scores indicate greater independence, while lower scores signify higher dependency on caregivers.
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90 Days
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Quality of Life, as measured by Neuro-QoL
大体时间：90 Days
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Neuro-QoL is a set of patient-reported outcome measures designed to assess health-related quality of life across physical, mental, and social domains relevant to individuals with neurological conditions.
It uses calibrated item banks and short forms to measure constructs such as mobility, cognitive function, emotional/behavioral health, fatigue, and social participation.
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90 Days
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Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS)
大体时间：90 Days
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COSMOS is a 7-point scale ranging from 0 (no symptoms) to 6 (loss of independence for an instrumental or basic activity of daily living or worse), which accounts for performance limitations and losses of a person's hobbies or passions and of their employment, educational, service, or caregiving pursuits, besides just activities of daily living.
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90 Days
|
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Safety events of interest
大体时间：Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
|
Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
|
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Treatment method per the physician's clinical judgment
大体时间：Baseline
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Alejandro Spiotta, MD、Medical University of South Carolina
- 首席研究员：Nitin Goyal, MD、University of Tennessee Health Science Center/Semmes Murphey Clinic
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月26日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年8月5日
首次发布 (实际的)
2026年8月6日
研究记录更新
最后更新发布 (实际的)
2026年8月6日
上次提交的符合 QC 标准的更新
2026年8月5日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.