FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenumbra Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular Thrombectomy
DevicePatients 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.
Medical Management
Other interventionAll 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Medical Management1 intervention
Group B: Endovascular Thrombectomy plus Medical Management2 interventions
Trial outcomes
Primary outcomes
1
Change in NIHSS at 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.
Time frame
24 hoursSecondary outcomes
1
90-day Modified Rankin Scale (mRS)
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.
Time frame
90 Days2
Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment
Time frame
Treatment/Procedure3
90-day NIHSS
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.
Time frame
90 Days4
Quality of Life, as measured by Barthel Index
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.
Time frame
90 DaysSponsors and contacts
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Source ClinicalTrials.gov