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

NCT07749170 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-08-06

No results posted yet for this 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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Alejandro Spiotta, MD · Medical University of South Carolina

  • Nitin Goyal, MD · University of Tennessee Health Science Center/Semmes Murphey Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749170 on ClinicalTrials.gov