Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-25 @ 6:35 PM
Study NCT ID:
NCT05217459
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2022-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of In-stent restenosis within 6 months after operation', 'timeFrame': '6 months after operation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Stent success', 'timeFrame': 'Immediately after operative', 'description': '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into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.'}, {'measure': 'Procedure success', 'timeFrame': 'Immediately after operative', 'description': 'Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.'}, {'measure': 'Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up', 'timeFrame': '6 months after operation', 'description': "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)."}, {'measure': 'Rate of good functional outcomes measured by Modified Rankin Score (mRS)', 'timeFrame': '30days, 6 months, 1 year after operation', 'description': '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.'}, {'measure': 'Rate of all revascularization and target lesion revascularization', 'timeFrame': '30days, 31days to 6 months, 1 year after operation', 'description': 'The proportion of patients who had revascularization in target lesion or not'}, {'measure': 'Symptomatic ISR within 6 months', 'timeFrame': 'within 6 months', 'description': 'Symptomatic ISR is defined as ISR associated with ischemic event in the territory'}, {'measure': '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.', 'timeFrame': '30days, 31days to 6 months, 1 year after operation', 'description': '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.'}, {'measure': 'Any stroke or death within 30 days after operation', 'timeFrame': 'Within 30 days after operation', 'description': 'Any stroke, death means death from any cause, including stroke or cerebrovascular disease'}, {'measure': 'Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel', 'timeFrame': 'Within 30 days after operation', 'description': 'The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion'}, {'measure': 'The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.', 'timeFrame': '31days to 6 months, 1 year after operation', 'description': 'There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.'}, {'measure': 'The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.', 'timeFrame': '31 days to 6 months, 1 year after operation', 'description': 'There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.'}, {'measure': 'Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage', 'timeFrame': '31 days to 6 months, 1 year after operation', 'description': 'There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage'}, {'measure': 'All cause death', 'timeFrame': '31days to 6 months, 1 year after operation', 'description': 'The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year after operation'}, {'measure': 'Adverse events or severe adverse event', 'timeFrame': '31 days to 6 months, 1 year after operation', 'description': 'The proportion of Adverse events or severe adverse event'}, {'measure': 'Incidence of device defects', 'timeFrame': 'During operation', 'description': 'The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-expanding intracranial stent', 'Symptomatic Intracranial Atherosclerotic Disease', 'In-stent restenosis'], 'conditions': ['Intracranial Arterial Diseases', 'Stent Restenosis', 'Percutaneous Transluminal Angioplasty']}, 'descriptionModule': {'briefSummary': 'The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 30 to 75 years of age;\n2. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;\n3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery\n4. 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;\n5. 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;\n6. mRS \\< 3;\n7. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;\n8. 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.\n\nExclusion Criteria:\n\n1. The target vessels was complete occlusion;\n2. \\>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;\n3. Preoperative magnetic resonance only showed perforating infarction in the target lesion area;\n4. 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;\n5. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;\n6. CT showed Severe calcified lesions;\n7. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);\n8. Non-atherosclerosis lesions;\n9. Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);\n10. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;\n11. 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;\n12. Hemoglobin \\<100g/L, platelet count \\<100\\*109/L, International normalized ratio (INR) \\>1.5 (irreversible) or uncorrectable hemorrhagic factors;\n13. Uncontrollable severe hypertension (systolic blood pressure\\>180mmHg or diastolic blood pressure\\>110mmHg)；\n14. Known liver or renal insufficiency (ALT\\> 3x upper limit or AST \\> 3x upper limit, Serum creatinine\\>250μmol/L);\n15. Life expectancy \\< 1 year;\n16. Pregnant/lactating female patients;\n17. Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);\n18. 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;\n19. Inapplicable for intravascular stenting treatment as per investigators judgment.'}, 'identificationModule': {'nctId': 'NCT05217459', 'briefTitle': 'The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sinomed Neurovita Technology Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SNSC-202103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-expanding intracranial drug stent system', 'description': 'All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)', 'interventionNames': ['Device: Self-expanding intracranial drug stent system']}], 'interventions': [{'name': 'Self-expanding intracranial drug stent system', 'type': 'DEVICE', 'description': 'All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)', 'armGroupLabels': ['Self-expanding intracranial drug stent system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Changzhou', 'country': 'China', 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': "Hangzhou First people's Hospital, Zhejiang University School of Medicine", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ha’erbin', 'country': 'China', 'facility': 'The First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 31.8696, 'lon': 101.742}}, {'city': 'Hefei', 'country': 'China', 'facility': 'The First Affiliated Hospital of USTC Anhui provincial hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jinan', 'country': 'China', 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Qingdao', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Fourth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shijiazhuang', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Yantai', 'country': 'China', 'facility': 'Yantai Yu Huang Ding hospital', 'geoPoint': {'lat': 37.47649, 'lon': 121.44081}}, {'city': 'Zhengzhou', 'country': 'China', 'facility': 'The First Affiliated hospital of Zhengzhou hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'jianming Liu, M.D/Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinomed Neurovita Technology Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}