[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MicroPort NeuroTech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,70,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100617086","the-liquid-embolic-agent-for-the-treatment-of-brain-arteriovenous-malformation-100617086",false,"NCT07314047","The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation","a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation","PARTNER","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 80 years at the time of signing the informed consent\n* Subjects with brain arteriovenous malformation diagnosed by CT\u002FMRI\u002FDSA\n* The target brain arteriovenous malformation is classified by Spetzler-Martin in the range of Ⅰ \\~ Ⅳ\n* Subjects themselves and\u002For their guardian are able to understand the purpose of the study, consent to participate, and sign the informed consent form\n* Brain arteriovenous malformations deemed suitable for liquid embolic agent intervention as assessed by the investigator\n\nExclusion Criteria:\n\n* Multiple brain arteriovenous malformations\n* Brain arteriovenous malformation complicated with blood flow-related aneurysm that may require staged and delayed treatment using other methods within the one-year follow-up period\n* Brain arteriovenous malformation with a history of stereotactic radiosurgery within 3 years\n* Brain arteriovenous malformation with bleeding within 1 week\n* Brain arteriovenous malformation with an expected number of embolizations ≥ 4\n* Brain arteriovenous malformation scheduled for surgical resection after embolization\n* mRS score ≥ 3\n* Subjects unsuitable for anesthesia or endovascular surgical treatment, due to major diseases of cardio, lung, liver, spleen or kidney, malignant brain tumors, severe active infection, disseminated intravascular coagulation, or a history of severe mental illness, etc\n* Subjects who undergo major surgical procedures (such as tumor resection, vital organ surgery, etc.) within 30 days prior to signing the informed consent form, or those scheduled for such procedures within 60 days after signing the informed consent form\n* Contraindications for liquid embolic agent treatment, including but not limited to: contraindications for DSA, severe allergy or intolerance to contrast agents, severe allergy or intolerance to antiplatelet or anticoagulant medications required for treatment, or severe allergy to tantalum metal\n* Pregnant or lactating women\n* Subjects participating in other drug or device studies that have not reached their endpoints or who have just withdrawn from the group for less than one month","ALL","18 Years","80 Years",{"count":21,"type":22},116,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc. DBA ev3 Neurovascular (NMPA (J) 20173136690). According to the inclusion and exclusion criteria specified in this trial protocol, approximately 116 subjects with brain arteriovenous malformation will be enrolled for interventional embolization treatment. The subjects will undergo follow-up before the surgery, after device implantation, at discharge, 1 month (± 7 days), 6 months (± 30 days), and 12 months (± 60 days) after the first embolization. When necessary, unscheduled follow-up will be conducted to record various indicators for evaluating the safety and effectiveness of liquid embolic agents in the treatment of brain arteriovenous malformations.",[28,29],"Brain Arteriovenous Malformation","Arteriovenous Fistula",[31,32,33],"brain arteriovenous malformation","arteriovenous fistula","LIQUID EMBOLIC AGENT","RECRUITING","2025-12-30",{"date":37,"type":38},"2026-01-02","ACTUAL",{"date":40,"type":38},"2024-05-28",{"date":42,"type":22},"2026-05-28",{"name":44,"class":45},"MicroPort NeuroTech Co., Ltd.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100587252","phase-3-a-randomized-trial-of-the-rapamycin-target-eluting-stent-for-the-treatment-of-symptomatic-cerebral-artery-atherosclerotic-diseasetarget-dream-100587252","NCT06925971","A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）","A Prospective, Multi-center, Open-label, Controlled, Superiority, Randomized, Controlled Registration Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM）","Inclusion Criteria:\n\n* 1\\) Age 18-80 years old\n* 2\\) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation\n* 3\\) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery\n* 4\\) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA\n* 5\\) Subject with at least one or more risk factors, including hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia, coronary artery disease, obesity, smoking history, etc\n* 6\\) Subject and\u002For their legal representatives have the necessary mental capacity to understand the study purpose, agree to participate in the study, and sign the informed consent form\n\nExclusion Criteria:\n\n* 1\\) mRS score≥3\n* 2\\) Last ischemic stroke onset within 2 weeks\n* 3\\) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.\n* 4\\) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging\n* 5\\) Hemorrhagic transformation in the territory of qualifying artery. Any parenchymal, subarachnoid, subdural, or extradural hemorrhage within 30 days prior to procedure, or untreated chronic subdural hematoma(≥5 mm) according to preoperative imaging\n* 6\\) Restenosis of qualifying lesion due to previous stenting.\n* 7\\) Qualifying lesion with severe calcification, extreme eccentricity, or extreme angulation which may affect stent deployment\n* 8\\) Stenosis caused by non-atherosclerotic lesions, such as arterial dissection, moya-moya disease, or vasculitis\n* 9\\) Concomitant severe stenosis (≥70% stenosis as measured by the WASID method) in the distal or proximal to qualifying lesion\n* 10\\) Concomitant multiple stenoses where qualifying lesions cannot be identified\n* 11\\) Thrombus in the qualifying artery or complete occlusion of the qualifying artery\n* 12\\) Severe calcification or tortuosity of qualifying artery to prevent stent from successful positioning and dilatation\n* 13\\) Stenting in qualifying artery within one year\n* 14\\) Concomitant aneurysms requiring treatment\n* 15\\) Concomitant intracranial malignant tumors, intracranial arteriovenous malformations, intracranial venous sinus thrombosis, or other conditions inappropriate to participate in the study\n* 16\\) Resistant hypertension (systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg) despite use of medication\n* 17\\) Acute myocardial infarction within 4 weeks prior to enrollment, or suspected cardiogenic embolism\n* 18\\) Subjects with severe systemic diseases that cannot tolerate surgery, such as severe hepatic or renal impairment\n* 19\\) Severe cognitive impairment or mental diseases\n* 20\\) Contraindications to anticoagulants or antiplatelet drugs, such as anticoagulant or antiplatelet drug allergy, active bleeding, or coagulation disorder\n* 21\\) Subjects with allergy or suspected allergy to anesthetics, contrast agents, rapamycin, polylactic acid, nickel-titanium alloy, cobalt-chromium alloy, stainless steel, and other stent materials, medications, and intraoperative medications\n* 22\\) Women who are pregnant or breastfeeding\n* 23\\) Subjects who are participating or planning to participate in any drug or device clinical study at the time of enrollment\n* 24\\) Life expectancy ≤ 1 year\n* 25\\) Other conditions inapplicable to participate in the study according to investigators' judgment",{"count":55,"type":22},279,[57],"PHASE3","The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:\n\n* Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)\n* Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group.\n\nConsidering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.\n\nMoreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration.\n\nOverall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.",[60],"Intracranial Arteriosclerosis","NOT_YET_RECRUITING","2025-04-11",{"date":64,"type":38},"2025-04-13",{"date":66,"type":22},"2025-04-15",{"date":68,"type":22},"2027-10-01",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":46},"100580923","a-pilot-trial-of-a-disposable-intracerebral-aspiration-endoscope-for-the-treatment-of-intracerebral-hematomafast-het-100580923","NCT06843616","A PILOT TRIAL of a DISPOSABLE INTRACEREBRAL ASPIRATION ENDOSCOPE for the TREATMENT of INTRACEREBRAL HEMATOMA（FAST-HET）","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years old;\n2. Spontaneous intracerebral hemorrhage;\n3. Hemorrhage located in the supratentorial subcortical or basal ganglia region;\n4. Hematoma volume ≥ 30ml and ≤ 80ml;\n5. Able to undergo surgery within 72 hours after onset;\n6. GCS score of 5 to 14;\n7. The subject themselves and\u002For their authorized representative can understand the purpose of the study, agree to participate, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of intracerebral hemorrhage within the past year;\n2. Traumatic intracerebral hemorrhage;\n3. Multiple intracerebral hemorrhages;\n\n   Note: Hemorrhage in the supratentorial subcortical or basal ganglia region that extends into the ventricles is not considered multiple hemorrhages and can be included.\n4. Known or suspected intracerebral hemorrhage caused by tumors, aneurysms, vascular malformations, hemorrhagic transformation of ischemic stroke, cerebral venous thrombosis, etc.;\n5. Formation of brain herniation;\n6. Severe neurological or psychiatric disorders before onset (such as epilepsy, Alzheimer's disease, Parkinson's disease, schizophrenia, depression, etc.);\n7. mRS score ≥ 3 before onset;\n8. Use of anticoagulants or antiplatelet drugs within 14 days before onset, or the need for long-term use of anticoagulants or antiplatelet drugs, or other factors causing coagulation dysfunction;\n9. Platelet count less than 100 × 10\\^3\u002FμL or international normalized ratio (INR) greater than 1.4;\n10. Active bleeding present, such as gastrointestinal bleeding, respiratory bleeding, or subcutaneous hematoma;\n11. Uncontrolled hypertension that cannot be managed with medication (systolic blood pressure \\> 220 mmHg or diastolic blood pressure \\> 120 mmHg after medication upon admission);\n12. Severe systemic diseases that cannot tolerate surgery, such as severe liver or kidney dysfunction;\n13. Women of childbearing age who are pregnant or breastfeeding;\n14. Currently participating in any drug or device research, or planning to participate in other drug or device clinical trials;\n15. Life expectancy ≤ 1 year;\n16. Other situations where the researcher deems the subject unsuitable for the study.",{"count":77,"type":22},16,[25],"This clinical trial is a prospective, open-label, single-arm clinical trial. According to the inclusion and exclusion criteria specified in the trial protocol, no fewer than 16 subjects with cerebral hemorrhage will be enrolled in 1 to 2 clinical centers. Considering the learning period required for doctor to become proficient in using the device, the first three cases at each research center are considered as the lead-in period cases and will not be included in the primary analysis dataset. During the surgery, a disposable intracerebral aspiration endoscope will be used to remove the intracerebral hematoma. Follow-ups will be conducted at discharge\u002FDay 7 (±1 day), postoperative 1 month (±7 days), and postoperative 3 months (±15 days). Recording various indicators to evaluate the safety and effectiveness of the disposable intracerebral aspiration endoscope in treating intracerebral hematoma.",[81],"Intracerebral Hemorrhage","2025-02-21",{"date":84,"type":38},"2025-02-25",{"date":86,"type":38},"2025-02-06",{"date":88,"type":22},"2025-10-31",{"name":44,"class":45},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":46},"100530681","registration-trial-of-the-intracranial-visualized-stent-for-the-wide-necked-intracranial-aneurysmsrebridge-100530681","NCT06189950","Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE","a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Intracranial Stent for the Treatment of Intracranial Aneurysms: Rebridge","Inclusion Criteria:\n\n* At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years； Target aneurysms was diagnosed as intracranial widenecked saccular aneurysms by DSA\u002FCTA\u002FMRA； The target aneurysm should be suitable for stentassisted coiling surgery and could be treated through one operation； Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\n* Aneurysms unsuitable for stent-assisted coiling (i.e. aneurysm necks ≤ 4 mm and or body-to-neck ratio ≥ 2)； The distal diameter of the aneurysm-carrying artery is outside the range of application of the investigational device; mRS score ≥3; Subjects with recurrent aneurysms treated by stent-assisted coiling; Multiple aneurysms and all aneurysms requiring intervention; Subjects with ruptured aneurysms \\\u003C30 days ; Significant stenosis (≥50%) or occlusion of parent artery; Subjects unsuitable for anaesthesia or endovascular surgical treatment, e.g. major diseases of the heart, lungs, liver, spleen and kidneys, brain tumours, severe active infections, disseminated intravascular coagulation, and a history of severe mental illness; Subjects undergoing major surgical procedures (e.g. tumour resection, surgery of vital organs, etc.) within 30 days prior to signing the informed consent form, or scheduled to undergo such procedures within 60 days after signing the informed consent form; Subjects with morphologies or pathologies that may interfere with device use, including, but not limited to: carotid artery coarctation, vasculitis, aortic coarctation, limited vascular access (e.g., severe intracranial vascular tortuosity, severe intracranial vasospasm unresponsive to medication, other anatomical or clinical pathologies that would prevent access to the device); Contraindications to stenting, including but not limited to: contraindication to DSA, allergy or intolerance to contrast media, allergy or intolerance to antiplatelet and anticoagulant medications required for treatment, allergy to nickel-titanium and platinum-tungsten and platinum-iridium alloys; Pregnant or breastfeeding women; Life expectancy less than 12 months; Subject participation in other drug or device studies that do not meet endpoints",{"count":98,"type":22},200,[25],"This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.",[102,103,104],"Brain Diseases","Aneurysm","Intracranial Aneurysm","2024-01-02",{"date":107,"type":38},"2024-01-05",{"date":109,"type":38},"2023-10-30",{"date":111,"type":22},"2026-10-30",{"name":44,"class":45},""]