Long-term Effects of Enterprise Self-expanding Intracranial Stent Implantation in the Treatment of Carotid Artery Stenosis in Patients With Ischemic Stroke: Study Protocol for a Randomized Controlled Trial

Atherosclerosis is a chronic degenerative disease that can cause intracranial carotid artery stenosis, which is a leading cause of ischemic stroke. The currently used interventions for carotid artery stenosis in ischemic stroke include internal medication, carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS). Internal medication for carotid artery stenosis is mainly performed to reduce risk factors for cerebrovascular disease, including anti-platelet aggregation, anticoagulation, lowering blood lipid and blood pressure, controlling blood glucose and improving living habits. As for patients with mild carotid artery stenosis, internal medication is generally recommended. Carotid endarterectomy has been confirmed to be a gold standard for the treatment of carotid artery stenosis. However, it is also limited by some factors including sophisticated technique, great trauma, general anesthesia, severe stroke, 9% fatality rate, and 7.6% cranial nerve injury. In addition, carotid endarterectomy is not suitable for patients with high-position or tandem carotid artery stenosis or carotid artery stenosis complicated by contralateral carotid artery occlusion. In recent years, CAS has been increasingly used for the treatment of carotid artery stenosis in patients with ischemic stroke because of its minimally invasive procedure, rapid recovery process and wide indications.

Enterprise stent system is a U.S. Food and Drug Administration (FDA)-approved closed loop recoverable self-expanding stent that has been confirmed to be highly effective in the treatment of intracranial aneurysm. Existing evidence on use of Enterprise stent system for intracranial artery stenosis in patients with ischemic stroke mainly focus on case series and case reports.

There is a lack of randomized controlled trial evidence regarding long-term effects of Enterprise stent implantation for the treatment of carotid artery stenosis after ischemic stroke. The existing related reports are case series or case reports with the caveats like non-randomized, non-blinded design with small sample sizes. Therefore, in this study, the investigators designed a double-blind, randomized, drug control trial to investigate the efficacy of Enterprise stent implantation in the treatment of carotid artery stenosis in patients with ischemic stroke.

Enterprise stent system is a novel closed loop self-expanding stent that is made of Ni-Ti alloy and shows favorable flexibility and ease in use, and its use was approved in 2009 in China. The current clinical evidence regarding use of Enterprise stent system mainly address on aneurismal treatment. In this study, the investigators will use Enterprise stent system to treat carotid artery stenosis in patients with ischemic stroke, which is of important clinical significance for secondary prevention of ischemic stroke. In addition, there is no long-term follow-up evidence regarding Enterprise stent implantation of carotid artery stenosis after ischemic stroke, so 3-year follow-up will be performed in this study.

In this study, simple antiplatelet drug will be used as controls to investigate the superiority of Enterprise stent implantation in combination with antiplatelet over antiplatelet medication only in the treatment of carotid artery stenosis. Outcomes from this study will add objective, rigorous, double-blind, randomized, controlled long-term follow-up trial evidence to Enterprise stent implantation for the treatment of carotid artery stenosis after ischemic stroke.