Evaluating the Safety and Efficacy of the Maurora® DES in ICAS

Study Overview
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Brief Summary
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The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) is more efficacious than bare metal stent (BMS) in prevention of in-stent restenosis (ISR) and improvement of outcomes for symptomatic intracranial atherosclerotic stenosis. This trial is prospective, multi-center, randomized 1:1 single blind trial using Maurora sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 10 interventional neurology centers in China. The study is sponsored by Alain Medical (Beijing) Co., Ltd.

Detailed Description
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This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent versus bare metal stent (BMS) to treat intracranial stenosis of 70-99% degree. The primary endpoint is in-stent restenosis rate(ISR) within 12 months after revascularization procedure of the qualifying lesion during follow-up.

Official Title
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A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the Maurora® Sirolimus-Eluting Stent Versus the Apollo Stent in Intracranial Atherosclerotic Stenosis(Maurora ICAS Trial)

Conditions
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Intracranial Arteriosclerosis, Stroke (CVA) or TIA

Intervention / Treatment
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* Device: Maurora® Sirolimus Eluting Stent System
* Device: APOLLO™ Intracranial Stent System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maurora® Sirolimus Eluting Stent System<br>Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys. | Device: Maurora® Sirolimus Eluting Stent System<br>* The Maurora® for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.<br>* Other names: Maurora;|
| Active Comparator: APOLLO™ Intracranial Stent System<br>Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system. | Device: APOLLO™ Intracranial Stent System<br>* The Apollo stent system comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.<br>* Other names: APOLLO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent restenosis rate(ISR) within 12 months after procedure | Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure | 12 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation success rate | Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system. | During the procedure | 
| Technical success rate | Technical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%. | During the procedure | 
| Clinical success rate | Clinical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%, and free from major adverse event within 12 months after procedure. system with a residual stenosis of <30% | 12 months after procedure | 
| Stroke or death within 30 days after procedure | Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death. | within 30 days after procedure | 
| Stroke in the target vessel territory or death within 30 days after procedure | Death or any stroke events related to target vessel after revascularization. | within 30 days after procedure | 
| Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure | Any ischemic stroke events related to target vessel after revascularization. | between 31 day to 1 year after procedure | 
| Ischemic stroke in other vessel territory between 31 day to 1 year after procedure | Any ischemic stroke events unrelated to target vessel after revascularization.Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. | between 31 day to 1 year after procedure | 
| Any ischemic stroke between 31 day to 1 year after procedure | Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. | between 31 day to 1 year after procedure | 
| Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure | Any subdural or epidural hemorrhage or a systemic hemorrhage is required hospitalization, blood transfusion, or surgery. | between 31 day to 1 year after procedure | 
| Death between 31 day to 1 year after procedure | All-cause death. | between 31 day to 1 year after procedure | 
| Transient Ischemic Attack within 1 year after the procedure | A transient ischemic attack (TIA) is a temporary period of symptoms similar to those of a stroke. A TIA usually lasts only a few minutes up to 24 hours and doesn't cause permanent damage. | 1 year after the procedure | 
| Functional outcome measured by the modified Rankin Scale | Focus on difference between 1 month and 12 months after procedure. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6 -Dead. A higher score indicates worse a outcome. | 1 and 12 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke