4 The barrel IDE study

Abstract

Introduction Wide-necked bifurcating aneurysms remain a significant challenge for endovascular treatment. Therefore, the Barrel VRD was designed to specifically address wide-neck bifurcating anatomy with a bulging center that has two ‘hinge’ segments to allow excellent apposition across the aneurysm neck. Materials and methods The Barrel IDE Study was an FDA approved, Prospective, Multi-Center, Single-Arm Study of the Barrel Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms of Middle Cerebral and Basilar Arteries. The primary effectiveness endpoint was the percentage of Barrel VRD treated aneurysms achieving Raymond Grade I (100% occlusion) at one year, in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture. The primary safety endpoint was the incidence of neurological death or major ipsilateral stroke at any time during the follow-up period. Results The BARREL IDE Study enrolled a total of 138 patients. The mean aneurysm neck size was 4.8±1.4 mm with aneurysm neck size up to 7.9 mm and dome/neck ratio of 1.3±0.4. The 12 month primary effectiveness endpoint was achieved in 63% of patients. The primary safety endpoint occurred in 3.9% (5/127) of subjects. Comprehensive final results of the Barrel IDE Study will be presented at the SNIS annual meeting. Conclusion The BARREL IDE Study demonstrates the safety and efficacy of an important new technology to treat challenging wide-neck, intracranial, bifurcation/branching aneurysms of Middle Cerebral and Basilar Arteries. Disclosures J. Mocco: 1; C; Medtronic. 2; C; TSP, Rebound Therapeutics, Viseon, Pulsar, Cerebrotech, Endostream, Vastrax. 4; C; Cerebrotech, TSP, Endostream, Apama, Rebound, Viseon, Neurvana, Cardinal Consulting, Blink TBI, Serenity, NTI. 5; C; Mount Sinai. 6; C; INVEST Study (Co-PI), COMPASS Study (Co-PI), THERAPY Study (PI), FEAT Study (PI), POSITIVE Study (Co-PI), BARREL Study (PI). S. Tateshima: 1; C; Medtronic. 2; C; Medtronic, Stryker, Cerenovus, Balt USA, Spartan Micro, NeuroVasc Technologies, ReBound Therapeutic, Century Medical, Walk Vascular, Python Vascular. 4; C; Balt USA, ReBound Therapeutic, Viseon Spine, Python Vascular, NeuroVasc Technologies, Spartan Micro. 5; C; University of California Los Angeles. 6; C; NAPA Study, Steering Committee, ARTISSE Trial Steering Committee, NeuroVasc Versi Study in Canada, DSMB Chair. D. Frei: 2; C; Cerenovus, Stryker, Penumbra, Genentech. 4; C; Penumbra. 5; C; RIA Radiology Imaging Associates. 6; C; Enterprise Stent IDE Trail (PI). A. Siddiqui: 2; C; Apama Medical, Cardinal Health, Cerenovus, Large Trial, ARISE II Trial, Claret Medical, Imperative Care, Integra, International Medical Distribution Partners, Medtronic, Microvention, Penumbra, 3D Separator Trial, COMPASS Trial, INVEST Trial, Rapid Medical, Rebound Therapeutics, Silk Road Medical, StimMed. 4; C; Amnis Therapeutics, BlinkTBI, Inc, Boston Scientific, Cerenovus, Claret Medical, Cognition Medical, Corindus, Inc., Guidepoint Global Consulting, Integra, StimMed. 6; C; Buffalo Technology Partners, Inc., Canon Medical Systems USA, Inc., Cerebrotech Medical Systems, Inc., Endostream Medical, Ltd., Guidepoint Global Consulting, Integra, Medtronic, Silk Road Medical.