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Clinical Trials in the USA / NCT07749170
Recruiting Observational

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

NCT07749170 · tracked via the Priya Life Science USA tracker
Sponsor
Penumbra Inc
Phase
Observational
Started
2026-06-26
Last updated
2026-10-29

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Endovascular ThrombectomyMedical Management

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in NIHSS at 24 hours — 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.

Trial sites (7)

FacilityCityRegionStatus
Swedish Medical Center Englewood Colorado Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
University of Kentucky Lexington Kentucky Recruiting
Wellspan York Hospital York Pennsylvania Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
Fort Sanders Regional Medical Center Knoxville Tennessee Recruiting
Semmes Murphey Memphis Tennessee Recruiting

More Penumbra Inc. trials in the USA

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System Recruiting
A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) Recruiting
BOLT-DVT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis Active, not recruiting

Other trials for the same condition

A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT Active, not recruiting
Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke Recruiting
Safety and Efficacy of J147 in Acute Ischemic Stroke Recruiting
A Phase 1b Study to Assess the Safety and Tolerability of AB126 Neural Exosomes in Patients With Moderate to Severe Acute Ischemic Stroke Starting soon
A Study of TAK-755 in Adults With Acute Ischemic Stroke Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07749170 on ClinicalTrials.gov ↗ ← All trials in the USA