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

Recruitingn/aAges 18 Years - anyAllPenumbra Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Endovascular Thrombectomy
  • Medical Management
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Where

5 sites
Swedish Medical Center
Englewood, United States
Yale New Haven Hospital
New Haven, United States
University of Kentucky
Lexington, United States
Fort Sanders Regional Medical Center
Knoxville, United States
Semmes Murphey
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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