FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenumbra Inc.
About this trial
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 criteria
Qualifiers
Participant age ≥ 18
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
NIHSS ≥5 or NIHSS 3-4 with disabling symptoms
Pre-stroke mRS 0-1
Disqualifiers
Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period.
Known multiple occlusions
Secondary M2 occlusion
Known or high suspicion of underlying ICAD as the cause of the M2 occlusion
Trial design
Treatments tested in this trial
- Endovascular Thrombectomy
- Medical Management
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov