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NCT Number: NCT07749170

FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions

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.

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Key information

Conditions

Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular Thrombectomy

Device

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 management

Other

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.

Primary outcomes

  1. Change in NIHSS at 24 hours

    Time frame: 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 outcomes

  1. 90-day Modified Rankin Scale (mRS)

    Time frame: 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.

  2. Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment

    Time frame: Treatment/Procedure

  3. 90-day NIHSS

    Time frame: 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.

  4. Quality of Life, as measured by Barthel Index

    Time frame: 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.

  5. Quality of Life, as measured by Neuro-QoL

    Time frame: 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.

  6. Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS)

    Time frame: 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.

  7. Safety events of interest

    Time frame: Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days

  8. Treatment method per the physician's clinical judgment

    Time frame: Baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Jelf

CONTACT

[email protected]

510-440-5719

Madeline Turtle

CONTACT

[email protected]

260-224-8231

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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