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.

introductionAcute 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. The primary effectiveness endpoint is amputation-free survival. Secondary outcomes include adverse events at 1 month postintervention, technical success rate, clinical-driven target lesion reintervention rate, primary patency of the lesions and health economics considerations. ETHICS AND DISSEMINATION: The RESOLVE clinical study is registered on ClinicalTrials.gov (http://clinicaltrials.gov/). Ethical approval was granted by the Institutional Review Board and the Human Research Ethics Committee of Hangzhou First People's Hospital (approval number: 2021No.15-1). Informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through publication in a reputable, peer-reviewed journal, contributing valuable insights to guide future clinical practice in this field. TRIAL REGISTRATION NUMBER: NCT04861506.