Background and purpose: Intravenous recombinant human tissue plasminogen activator (IV rtPA) therapy has limited revascularization rates in large artery occlusions. We describe the safety and effectiveness of the self-expanding, fully retrievable Separator 3D device as a component of the Penumbra System in revascularization of large artery occlusion in acute ischemic stroke. The 3D secures thrombus with lesional aspiration and functions by retrieving or debulking the clot.
Materials and methods: Prospective, single-center pilot study of 20 patients with an acute ischemic stroke secondary to a large artery occlusion within 9 h from symptom onset. The occlusion sites were middle cerebral artery in nine patients, internal carotid artery terminus in eight patients, and basilar artery in three patients. Thrombectomy was performed in 18 patients who had previously received IV rtPA, and of these, two patients had prior failed treatment with the Solitaire stent. One patient had prior failed treatment with the Revive stent.
Results: Successful revascularization defined by Thrombolysis in Cerebral Infarction grade 2b-3 was achieved in 17 of 20 (85%) treated vessels. The median time from symptom onset to recanalization was 4.4 h (interquartile range 3.8-5.6 h). No procedural complications occurred, and no symptomatic intracranial hemorrhage was observed. Three (15%) patients died. At 90 days, 50% of patients showed good functional outcome (modified Rankin Scale score ≤ 2).
Conclusion: Early results suggest that the Separator 3D, which combines a retriever with lesional aspiration, enables safe and effective revascularization.