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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-expanding intracranial drug stent system | Experimental | All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-expanding intracranial drug stent system | Device | All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES) |
| 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 |
| 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into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianming Liu, M.D/Ph.D | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | China | ||||
| The First Hospital of Jilin University |
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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 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 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 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. | 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 | 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 | 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. | 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. | 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 | 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 | 31days to 6 months, 1 year after operation |
| Adverse events or severe adverse event | The proportion of Adverse events or severe adverse event | 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. | During operation |
| Changchun |
| China |
| The First People's Hospital of Changzhou | Changzhou | China |
| 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 |
| Shanghai Fourth People's Hospital | Shanghai | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | China |
| Yantai Yu Huang Ding hospital | Yantai | China |
| The First Affiliated hospital of Zhengzhou hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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