Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction

• DOI: 10.1161/circinterventions.121.010960
• Publication Date: 2022-02-02T10:00:13Z
• Authors: Erin Murphy; Kathleen Gibson; Marc Sapoval; David J. Dexter; Raghu Kolluri; Mahmood Razavi; Stephen Black
• Keywords: Post-thrombotic syndrome

Background: Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate safety and effectiveness Abre self-expanding stent system for treatment symptomatic iliofemoral outflow obstruction. Methods: The ABRE Study (A Multi-Center, Non-Randomized Evaluate Safety Effectiveness Venous Self-Expanding Stent System Patients With Symptomatic Outflow Obstruction) a single-arm, multicenter, prospective that included 200 subjects from 24 global sites. primary end points were 12-month patency major adverse events within 30 days. Secondary lesion procedure success, primary-assisted secondary patency, events, migration, fracture, quality life changes. End point-related imaging studies adjudicated by independent clinical committee core laboratories, respectively. Results: was classified acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac (36.0%, 72/200). common external veins stented 96.0% (192/200), 80.5% (161/200) subjects, implant into femoral required 44.0% (88/200). Primary at 12 months 88.0% (162/184). Four (2.0%) occurred Twelve-month 91.8% (169/184) 92.9% (171/184), No fractures migrations reported. Mean target limb Villalta score decreased 11.2±5.6 baseline 4.1±4.8 months, mean revised Clinical Severity Score 8.8±4.7 4.3±3.6 months. Clinically meaningful improvements functional assessment scores demonstrated through all measures. Conclusions: can be successfully treated an stent. outcomes high rate good profile. significant reduction improvement maintained follow-up. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03038438.