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

August 5, 2026 updated by: Penumbra Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Recruiting
        • Fort Sanders Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Medical Management
Other: Medical 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.
Endovascular Thrombectomy plus Medical Management
Other: Medical 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.
Device: Endovascular 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
90 Days
Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment
Time Frame: Treatment/Procedure
Treatment/Procedure
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.
90 Days
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.
90 Days
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.
90 Days
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.
90 Days
Safety events of interest
Time Frame: Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days
Treatment method per the physician's clinical judgment
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alejandro Spiotta, MD, Medical University of South Carolina
  • Principal Investigator: Nitin Goyal, MD, University of Tennessee Health Science Center/Semmes Murphey Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 33727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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