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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

FORWARD is a prospective, multicenter, international observational study aiming to collect safety and effectiveness data on Penumbra System reperfusion catheters in patients with isolated primary non-dominant and distal M2 occlusions undergoing mechanical thrombectomy, as well as those treated with medical management alone. Treatments are chosen by physicians based on standard care at each site, and all participants are followed for 90 days. The study includes adults with confirmed distal M2 occlusions, moderate to severe stroke symptoms, and favorable pre-stroke function, with enrollment contingent on informed consent. Data will describe real-world outcomes across two management strategies and assess how they perform in routine clinical practice. No randomization is involved; researchers observe existing treatment decisions and collect safety and effectiveness information.

Why it matters

Who can join: the full rules

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

Where it's running

• Swedish Medical Center
  Englewood, Colorado, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Wellspan York Hospital
  York, Pennsylvania, United States Recruiting
• Medical University of South Carolina (MUSC)
  Charleston, South Carolina, United States Recruiting
• Fort Sanders Regional Medical Center
  Knoxville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Alejandro Spiotta, MD — Medical University of South Carolina
• Study coordinator: Madeline Turtle
• Email: MTurtle@PENUMBRAINC.COM
• Phone: 260-224-8231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.