Design of the RESOLVE study: a prospective, multicentre, observational, cohort study evaluating the safety and efficacy of endovascular treatment for acute or subacute thromboembolic occlusions of the lower extremity in China

作者：Jianyun Long, Linjun Wang, Chang-Pin Huang, Xupin Xie, Yongchang Liu, Yu‐Kai Chen, Hanyi Liu, Qihong Ni, Shuofei Yang, Ziheng Wu, Lianrui Guo, Zibo Feng, Qiang Li, Chunshui He, Hongfei Sang, Zhenyu Shi, Meng Ye, Xin Fang · 发表于：BMJ Open · 年份：2025 · DOI：10.1136/bmjopen-2025-103283 · 被引用次数：1 · 研究领域：Peripheral Artery Disease Management、Diagnosis and Treatment of Venous Diseases、Vascular Procedures and Complications

INTRODUCTION: Acute and subacute thrombotic occlusions of the lower extremities are common subtypes of peripheral artery disease frequently encountered in clinical practice. These occlusions typically involve the obstruction of a native artery or bypass graft, primarily caused by thrombosis or embolism. Endovascular therapy has increasingly become the preferred first-line treatment for patients with acute or subacute thromboembolic occlusions in the lower extremities. Thrombectomy, the removal of the thrombus, represents a critical initial step in endovascular management. A range of thrombectomy devices is currently available to treat such occlusions. However, the efficacy and safety of endovascular treatments remain uncertain, with real-world evidence on thrombectomy devices showing inconsistency across studies and clinical settings. This study aims to rigorously assess the safety and efficacy outcomes of endovascular treatment strategies for acute or subacute thromboembolic occlusions in the lower extremities. METHODS AND ANALYSIS: This prospective, cohort, multicentre, real-world observational study will enrol 400 patients diagnosed with acute or subacute thromboembolic occlusions of the lower extremity, treated with endovascular therapy across nine centres from 1 January 2021 to 31 December 2025. Participants will be followed for 12 months, with relevant demographic and clinical data collected. Follow-up assessments will occur at 1, 3, 6 and 12 months postintervention. Th...