The goal of the Penumbra System® Separator 3D Trial (3D RCT) is to assess the safety and effectiveness of the 3D as a component of the Penumbra System® in the revascularisation of large vessel occlusion in acute ischaemic stroke. The novel Separator 3D, with intraluminal chambers to secure clot, should provide more effective clot removal with the large inner diameter aspiration catheters.Materials and Methods
The 3D RCT is a prospective, multicentre, randomised, concurrent controlled, non-inferiority study. Up to 230 patients from 18 to 85 years old who present with large vessel occlusion (≥2.5mm) within 8 hours of symptom onset and are refractory to or not eligible for IV rtPA therapy are eligible. Patients with an NIHSS score of 8 or greater are randomised (1:1) to treatment with the Penumbra System including the 3D device or the Penumbra System alone. The primary endpoints are revascularisation of the target vessel as defined by a TICI score of 2 or 3 and incidence of 24-hour serious adverse events (SAEs). An independent, blinded Core Lab will review and assess imaging scans for TICI scores and ICH. A Clinical Event Committee/Data Safety Monitoring Board will evaluate SAEs and monitor safety. Secondary endpoints include good 90-day neurological and functional outcomes (NIHSS, mRS scores), all cause mortality, and incidence of symptomatic intracranial haemorrhage.Results
To date, 25 centres are screening, and 80 patients are enrolled, of which 49 are randomised.Conclusion
The Separator 3D Trial will determine if inclusion of a novel 3 dimensional clot retriever as a component of the Penumbra System® provides efficient revascularisation with acceptable safety.Disclosures
D. Frei: 3; C; Penumbra, Inc. A. Siddiqui: None. R. Nogueira: None. E. Mualem: 5; C; Penumbra, Inc. S. Sit: 5; C; Penumbra, Inc. 6; C; Penumbra, Inc. A. Bose: 4; C; Penumbra, Inc. 5; C; Penumbra, Inc.