Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEndovascular Thrombectomy
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.
OTHERMedical 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.
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant age ≥ 18 2. 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 3. NIHSS ≥5 or NIHSS 3-4 with disabling symptoms 4. Pre-stroke mRS 0-1 5. For participants undergoing thrombectomy: Planned first-line treatment with Penumbra System reperfusion catheters 6. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion criteria
1. Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period. 2. Known multiple occlusions 3. Secondary M2 occlusion 4. Known or high suspicion of underlying ICAD as the cause of the M2 occlusion 5. 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 6. 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. 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NIHSS at 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day Modified Rankin Scale (mRS) | 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. |
| Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment | Treatment/Procedure | — |
| 90-day NIHSS | 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. |
| Quality of Life, as measured by Barthel Index | 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. |
| Quality of Life, as measured by Neuro-QoL | 90 Days | 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. |
| Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS) | 90 Days | 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. |
| 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 | — |
Countries
United States
Contacts
CONTACTMadeline Turtle
CONTACTJennifer Jelf
PRINCIPAL_INVESTIGATORAlejandro Spiotta, MD
Medical University of South Carolina
PRINCIPAL_INVESTIGATORNitin Goyal, MD
University of Tennessee Health Science Center/Semmes Murphey Clinic
Outcome results
None listed