Evaluating the Safety and Efficacy of the Maurora® DES in ICAS (Maurora ICAS)
Intracranial Arteriosclerosis, Stroke (CVA) or TIA
About this trial
This is an interventional treatment trial for Intracranial Arteriosclerosis focused on measuring Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke
Eligibility Criteria
Inclusion Criteria: Age from 18 to 85 years; Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment); A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method); The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm; Only one stent planned for the target lesion; A Modified Rankin Score of ≤ 3; Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent. Exclusion Criteria: Ischemic stroke within 2 weeks before the procedure; Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion; Patients with stroke caused by perforating artery occlusion; Severe calcification at target lesion; Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks; History of stenting or angioplasty of an intracranial artery; Intracranial tumor, aneurysm or intracranial arteriovenous malformation; Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization; Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation); Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure; Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents; Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit); Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery; Life expectancy <12 months; Pregnant or lactating women, or planning for pregnancy; Participated in another investigational device or drug study within 30 days; According to the judgement of the investigator, other situations that are not suitable for enrollment.
Sites / Locations
- Beijing Tiantan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Maurora® Sirolimus Eluting Stent System
APOLLO™ Intracranial Stent System
Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.
Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.