O-020 The tigertriever 13 distals study: distal ischemic stroke treatment with adjustable low-profile stentriever. (23rd July 2022)

• Record Type: Journal Article
• Authors: Fiorella, D; Gupta, R; Chapot, R; Saver, J
• Is Part Of: Journal of neurointerventional surgery. Volume 14(2022)Supplement 1
• Page Start: A13
• Page End: A13
• Publication Date: 2022-07-23
• Subjects: Nervous system -- Surgery -- Periodicals; Cerebrovascular disease -- Surgery -- Periodicals; 617.48
• DOI: 10.1136/neurintsurg-2022-SNIS.20
• Languages: English
• ISSNs: 1759-8478

Abstract

Abstract : Objectives: This is the first FDA approved IDE study for mechanical thrombectomy to treat distal occlusions. DISTALS is a randomized study planned to evaluate the safety and effectiveness of the TIGERTRIEVER 13 Revascularization Device in restoring blood flow in the neurovasculature by removing thrombus in subjects presenting within 24 hours of onset with an ischemic stroke with disabling neurological deficits due to a primary distal vessel occlusion (DVO), as compared to medical management. Methods: 118 patients of age 18–85 will be randomized in 1:1 ratio in USA and outside USA clinical centers. The primary endpoint will be successful reperfusion at 24 ± 6 hours post randomization, measured either by CTP or MR PWI. The secondary endpoints will include 90 days mRS shift, delta NIHSS at discharge compared to baseline, Quality of life measured by EQ-5D and cognitive assessment measured by MoCA at 90 days. Safety endpoints will include symptomatic and asymptomatic intracranial hemorrhages. Key inclusion criteria will be disabling presenting deficits that localize to the territory of the distal vessel occlusion; NIHSS 4–24, or NIHSS 2–24 for patients with aphasia and/or hemianopia, CTP or MR PWI confirmed lesions non-dominant or co-dominant M2, M3, PCA or ACA; 24 hours since last known well. Patients with excessive tortuosity, treated with IV thrombolysis therapy, intracranial hemorrhage, bilateral stroke or stroke in multiple territories will be excluded. CT, MRI and Radiographic Images will be analyzed by an independent core lab (UCLA). Results: Technical aspects of the TIGERTIEVER 13 device, will be presented as well as summary of the European experience with the device. More study details and the study status will be discussed. Conclusion: The TIGERTRIEVER 13 device with operator controllability and high fluoroscopy visibility and its small size can potentially provide a safe and effective clot removal in patients with distal vessels occlusion. Disclosures: D. Fiorella: 1; C; Rapid Medical. R. Gupta: None. R. Chapot: None. J. Saver: None.