Study Comparing Endovascular Stenting Plus Medical Therapy Versus Medical Therapy Alone for Severe Asymptomatic Carotid Artery Narrowing in Adults Aged 40 to 80

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining endovascular stenting with optimal medical therapy compared to medical therapy alone in patients with severe narrowing 70-99% of the internal carotid artery who have no symptoms. This large, multicenter, randomized controlled trial plans to enroll 982 patients aged 40 to 80 years who have not experienced related neurological symptoms in the past six months and have declined surgery. The study aims to provide strong evidence to guide treatment choices for asymptomatic carotid artery stenosis. Participants will be randomly assigned to receive either endovascular stenting plus best medical therapy including antiplatelet drugs, statins, and risk factor control or best medical therapy alone. The stenting procedure involves accessing the artery through the femoral or radial artery and using an embolic protection device. Dual antiplatelet therapy is given before and after the procedure, followed by aspirin alone. Both groups will have regular follow-ups to monitor treatment adherence and outcomes. During the study, researchers will assess the occurrence of stroke, heart attack, or death within 30 days and up to one year after treatment or enrollment. Other evaluations include procedural success, artery narrowing recurrence, and changes in cognitive function measured by MoCA and MMSE tests. The study will last from 2024 to 2028, with a 12-month follow-up for each participant, and includes independent review of clinical events to ensure unbiased results.

Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis