Intracranial Arterial Diseases, Percutaneous Transluminal Angioplasty, Stent Restenosis
Conditions
Keywords
Self-expanding intracranial stent, Symptomatic Intracranial Atherosclerotic Disease, In-stent restenosis
Brief summary
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
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.
Interventions
DEVICESelf-expanding intracranial drug stent system
All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)
Sponsors
Changhai Hospital
Sinomed Neurovita Technology Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 30 to 75 years of age; 2. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery; 3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery 4. 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; 5. 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; 6. mRS \< 3; 7. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure; 8. 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
1. The target vessels was complete occlusion; 2. \>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; 3. Preoperative magnetic resonance only showed perforating infarction in the target lesion area; 4. 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; 5. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery; 6. CT showed Severe calcified lesions; 7. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation); 8. Non-atherosclerosis lesions; 9. Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks); 10. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation; 11. 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; 12. Hemoglobin \<100g/L, platelet count \<100\*109/L, International normalized ratio (INR) \>1.5 (irreversible) or uncorrectable hemorrhagic factors; 13. Uncontrollable severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg)； 14. Known liver or renal insufficiency (ALT\> 3x upper limit or AST \> 3x upper limit, Serum creatinine\>250μmol/L); 15. Life expectancy \< 1 year; 16. Pregnant/lactating female patients; 17. Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis); 18. 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; 19. Inapplicable for intravascular stenting treatment as per investigators judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of In-stent restenosis within 6 months after operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | Immediately after operative | Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method. |
| Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up | 6 months after operation | 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). |
| Rate of good functional outcomes measured by Modified Rankin Score (mRS) | 30days, 6 months, 1 year after operation | 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. |
| Rate of all revascularization and target lesion revascularization | 30days, 31days to 6 months, 1 year after operation | The proportion of patients who had revascularization in target lesion or not |
| Symptomatic ISR within 6 months | within 6 months | Symptomatic ISR is defined as ISR associated with ischemic event in the territory |
| 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. | 30days, 31days 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. |
| Any stroke or death within 30 days after operation | Within 30 days after operation | Any stroke, death means death from any cause, including stroke or cerebrovascular disease |
| Stent success | Immediately after operative | 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. |
| The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation. | 31days 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. |
| The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation. | 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. |
| Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage | 31 days to 6 months, 1 year after operation | There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage |
| All cause death | 31days to 6 months, 1 year after operation | The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year after operation |
| Adverse events or severe adverse event | 31 days to 6 months, 1 year after operation | The proportion of Adverse events or severe adverse event |
| Incidence of device defects | During operation | The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc. |
| Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel | Within 30 days after operation | The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion |
Countries
China
Outcome results
None listed