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

NCT07749170 | Recruiting FDA Device

• 1 other identifier: 33727
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

Outcome Measures

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.

  24 hours

Secondary Outcomes (8)

• 90-day Modified Rankin Scale (mRS)

  90 Days

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

  Treatment/Procedure

• 90-day NIHSS

  90 Days

• Quality of Life, as measured by Barthel Index

  90 Days

• Quality of Life, as measured by Neuro-QoL

  90 Days

Study Arms (2)

Medical Management

Other: Medical Management

Endovascular Thrombectomy plus Medical Management

Device: Endovascular Thrombectomy; Other: Medical Management

Interventions

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.

Endovascular Thrombectomy plus Medical Management

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.

Endovascular Thrombectomy plus Medical Management; Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Fort Sanders Regional Medical Center

Knoxville, Tennessee, 37916, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Alejandro Spiotta, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Nitin Goyal, MD

  University of Tennessee Health Science Center/Semmes Murphey Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Turtle

CONTACT

260-224-8231; MTurtle@PENUMBRAINC.COM

Jennifer Jelf

CONTACT

510-440-5719; jjelf@penumbrainc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 6, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)