The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
128
All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
The First Hospital of Jilin University
Changchun, China
The First People's Hospital of Changzhou
Changzhou, China
The incidence of In-stent restenosis within 6 months after operation
ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.
Time frame: 6 months after operation
Stent success
Stent success is defined as ISS is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.
Time frame: Immediately after operative
Procedure success
Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.
Time frame: Immediately after operative
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time frame: 6 months after operation
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Hangzhou First people's Hospital, Zhejiang University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
The First Affiliated Hospital of USTC Anhui provincial hospital
Hefei, China
Qilu Hospital, Shandong University
Jinan, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Changhai Hospital
Shanghai, China
...and 4 more locations
Time frame: 30days, 6 months, 1 year after operation
Rate of all revascularization and target lesion revascularization
The proportion of patients who had revascularization in target lesion or not
Time frame: 30days, 31days to 6 months, 1 year after operation
Symptomatic ISR within 6 months
Symptomatic ISR is defined as ISR associated with ischemic event in the territory
Time frame: within 6 months
Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.
As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.
Time frame: 30days, 31days to 6 months, 1 year after operation
Any stroke or death within 30 days after operation
Any stroke, death means death from any cause, including stroke or cerebrovascular disease
Time frame: Within 30 days after operation
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion
Time frame: Within 30 days after operation
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.
There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.
Time frame: 31days to 6 months, 1 year after operation
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.
There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.
Time frame: 31 days to 6 months, 1 year after operation
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
Time frame: 31 days to 6 months, 1 year after operation
All cause death
The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year after operation
Time frame: 31days to 6 months, 1 year after operation
Adverse events or severe adverse event
The proportion of Adverse events or severe adverse event
Time frame: 31 days to 6 months, 1 year after operation
Incidence of device defects
The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
Time frame: During operation