FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in NIHSS at 24 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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
研究组 & 干预措施
Medical Management
干预措施: Medical Management (Other)
Endovascular Thrombectomy plus Medical Management
干预措施: Endovascular Thrombectomy (Device)
Endovascular Thrombectomy plus Medical Management
干预措施: Medical Management (Other)
结局指标
主要结局
Change in NIHSS at 24 hours
时间窗: 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.
次要结局
- 90-day Modified Rankin Scale (mRS)(90 Days)
- Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment(Treatment/Procedure)
- 90-day NIHSS(90 Days)
- Quality of Life, as measured by Barthel Index(90 Days)
- Quality of Life, as measured by Neuro-QoL(90 Days)
- Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS)(90 Days)
- Safety events of interest(Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days)
- Treatment method per the physician's clinical judgment(Baseline)