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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
156
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.
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.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
In-stent restenosis rate(ISR) within 12 months after procedure
Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure
Time frame: 12 months after procedure
Implantation success rate
Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system.
Time frame: 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%.
Time frame: 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%
Time frame: 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.
Time frame: 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.
Time frame: within 30 days after procedure
Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure
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Any ischemic stroke events related to target vessel after revascularization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: between 31 day to 1 year after procedure
Death between 31 day to 1 year after procedure
All-cause death.
Time frame: 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.
Time frame: 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.
Time frame: 1 and 12 months after procedure