Phase
Condition
Coronary Artery Disease
Vascular Diseases
Hypercholesterolemia
Treatment
APOLLO™ Intracranial Stent System
Maurora® Sirolimus Eluting Stent System
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age from 18 to 80 years;
Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemicattack [TIA] associated with intracranial atherosclerosis within 90 days ofenrollment);
A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, orbasilar artery) with 70% to 99% stenosis on the angiography (According to WASIDmethod);
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 makehim/herself understood, and has provided informed consent.
Exclusion
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 orextradural 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 otherviral vascular diseases, neurosyphilis, any other intracranial infections,radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease,neurofibromatosis, central nervous system benign vascular disease, post-partumvascular 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 orpulmonary 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 requiringsimultaneous 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 notsuitable for enrollment.
Study Design
Study Description
Connect with a study center
Beijing Tiantan Hospital
Beijing, Beijing 100070
ChinaSite Not Available

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