The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

Study Overview
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Brief Summary
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The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Detailed Description
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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, and 2 years.

Official Title
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A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease

Conditions
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Intracranial Arterial Diseases, Stent Restenosis, Percutaneous Transluminal Angioplasty

Intervention / Treatment
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* Device: Self-expanding intracranial drug stent system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 to 75 years of age; Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery; Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment; The target lesion reference diameter must be visually estimated to be ≥2.0 mm and <4.5mm in diameter, and lesion length of ≤34 mm; mRS < 3; The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure; Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial. Exclusion Criteria: The target vessels was complete occlusion; >70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel; Preoperative magnetic resonance only showed perforating infarction in the target lesion area; Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm; Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery; CT showed Severe calcified lesions; Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation); Non-atherosclerosis lesions; Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks); Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation; Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents; Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors; Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)； Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250μmol/L); Life expectancy < 1 year; Pregnant/lactating female patients; Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis); Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint; Inapplicable for intravascular stenting treatment as per investigators judgment.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-expanding intracranial drug stent system<br>All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES) | Device: Self-expanding intracranial drug stent system<br>* All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 30days, 6 months, 1 year ,2 years after operation | 
| Rate of all revascularization and target lesion revascularization | The proportion of patients who had revascularization in target lesion or not | 30days, 31days to 6 months, 1 year, 2 years after operation | 
| Symptomatic ISR within 6 months | Symptomatic ISR is defined as ISR associated with ischemic event in the territory | 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, 2 years 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, 2 years after operation. | 30days, 31days to 6 months, 1 year, 2 years after operation | 
| Any stroke or death within 30 days after operation | Any stroke, death means death from any cause, including stroke or cerebrovascular disease | Within 30days 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 | Within 30days after operation | 
| The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation. | There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke. | 31days to 6 months, 1 year, 2 years after operation | 
| The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year, 2 years after operation. | There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke. | 31days to 6 months, 1 year, 2 years 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 | 31days to 6 months, 1 year, 2 years after operation | 
| All cause death | The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year, 2 years after operation | 31days to 6 months, 1 year, 2 years after operation | 
| Adverse events or severe adverse event | The proportion of Adverse events or severe adverse event | 31days to 6 months, 1 year, 2 years after operation | 
| Incidence of device defects | The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc. | During operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-expanding intracranial stent, Symptomatic Intracranial Atherosclerotic Disease, In-stent restenosis