Penumbra Inc.
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.
FORWARD is a prospective, multicenter, observational study that will be conducted internationally. Participants who satisfy all inclusion criteria and none of the exclusion criteria will be eligible for enrollment. They will receive treatment according to the physicians' clinical judgement per standard of care at their institution.
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 requir…
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.
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.
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