Acute Ischemic StrokeNCT07749170
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
An observational study of Acute Ischemic Stroke and Acute Ischemic Stroke (AIS) Related to a Distal Occlusion, run by Penumbra Inc. at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
- What is being tested?
- Endovascular Thrombectomy and Medical Management
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Jun 2026to Sep 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Swedish Medical Center
Englewood, Colorado, 80113
- Recruiting
Fort Sanders Regional Medical Center
Knoxville, Tennessee, 37916
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
- Recruiting
Semmes Murphey
Memphis, Tennessee, 38104
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
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.
Read the 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.
- Being tested
- Endovascular Thrombectomy, Medical Management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyDevice
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.
Medical ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | Not described Receives: Other: Medical Management | |
| Endovascular Thrombectomy plus Medical Management | Not described Receives: Device: Endovascular Thrombectomy; Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (8)
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.
Measured: 90 Days
Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment
Measured: Treatment/Procedure
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.
Measured: 90 Days
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.
Measured: 90 Days
Quality of Life, as measured by Neuro-QoL
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.
Measured: 90 Days
Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS)
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.
Measured: 90 Days
Safety events of interest
Measured: Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
Treatment method per the physician's clinical judgment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start26 Jun 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alejandro Spiotta, MD, Principal investigator, Medical University of South CarolinaNitin Goyal, MD, Principal investigator, University of Tennessee Health Science Center/Semmes Murphey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749170
- Sponsor's protocol ID
- 33727
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No