Transcranial Doppler for internal carotid artery stenting: rationale and design of a randomized controlled trial

Abstract

Background Carotid artery stenting (CAS) is an effective revascularization procedure for internal carotid artery stenosis, but it is associated with a high incidence of perioperative cerebral embolism, with asymptomatic and symptomatic embolic events occurring in up to 40% of patients. Transcranial Doppler (TCD) has been shown to enhance fibrinolysis through sonothrombolysis and may reduce embolic burden during carotid interventions. Aims To evaluate whether intraoperative and post-procedural TCD monitoring can reduce the number of new diffusion-weighted imaging (DWI) lesions after CAS in patients with severe internal carotid artery stenosis. Sample size estimates A total of 232 patients are required to detect a 50% reduction in the median number of new DWI lesions (from 2.0 to 1.0) with 80% power and a two-sided α of 0.05, accounting for a 5% dropout rate. Design TCD-ICAS is a prospective, randomized, single-center, blinded endpoint trial. Patients scheduled for CAS are randomized 1:1 to receive either TCD treatment (1.6 MHz, 0.274 MPa) from femoral artery puncture until 30–60 min after procedure completion plus standard care, or standard care alone. Outcomes The primary efficacy endpoint is the number of new DWI lesions at 24 h post-randomization. The primary safety endpoint is intracranial hemorrhage within 24 h. Conclusion The TCD-ICAS trial will assess the efficacy and safety of TCD as an adjuvant therapy to reduce cerebral embolic events in patients undergoing CAS. Clinical trial registration Identifier (NCT07462546).