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RECRUITING
NCT07749170

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

Sponsor: Penumbra Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2026-06-26

Completion Date

2028-09

Last Updated

2026-10-15

Healthy Volunteers

No

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.

Locations (5)

Swedish Medical Center

Englewood, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

University of Kentucky

Lexington, Kentucky, United States

Fort Sanders Regional Medical Center

Knoxville, Tennessee, United States

Semmes Murphey

Memphis, Tennessee, United States