[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Wecan Medical Technology Co.,Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100587146","study-on-the-trans-carotid-artery-occlusion-shunt-system-100587146",false,"NCT06924593","Study on the Trans-Carotid Artery Occlusion Shunt System","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment","Inclusion Criteria:\n\n* Age \\> 18 years;\n* For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:\n\n  1. Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack (TIA), and\u002For amaurosis fugax within 180 days before the operation.\n  2. Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \\> 70%, and the patient has not experienced any neurological symptoms within 180 days before the operation.\n* The modified Rankin Scale (mRs) score ≤ 2 before enrollment.\n* The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study:\n\nAnatomical high-risk:\n\nA. Contralateral carotid artery occlusion; B. Presence of tandem stenosis in the internal carotid artery with a stenosis degree \\> 70%; C. Carotid artery stenosis above the C2 vertebral body; D. Restenosis after previous ipsilateral carotid endarterectomy; E. Bilateral carotid artery stenosis requiring treatment (treatment of the contralateral vessel should be carried out at least 30 days after the operation); F. \"Difficult neck\" suitable for the transcarotid approach as evaluated by the researcher, including but not limited to: history of previous neck radiotherapy, history of previous radical neck lymph node dissection, neck stoma or limited cervical spine mobility.\n\nComorbid high-risk:\n\nG. The patient's age is ≥ 70 years old; H. The patient has coronary artery disease involving \\> 2 vessels and has a history of angina pectoris of any severity; I. The patient has a history of angina pectoris, with Canadian Cardiovascular Society (CCS) angina class 3 or 4, or unstable angina pectoris (defined as resting angina pectoris accompanied by electrocardiogram changes); J. The patient has congestive heart failure (CHF) - New York Heart Association (NYHA) functional class 3 or 4; K. The patient is known to have severe left ventricular dysfunction with a left ventricular ejection fraction (LVEF) \\\u003C 30%; L. The patient has experienced a myocardial infarction within 72 hours to 6 weeks before the operation; M. The patient has severe pulmonary disease (chronic obstructive pulmonary disease, COPD), with a forced expiratory volume in one second (FEV1) \\\u003C 50% (predicted value), or has been receiving long-term oxygen therapy, or has an arterial partial pressure of oxygen (PO2) ≤ 60 mmHg (room air) at rest; N. The patient has permanent contralateral cranial nerve injury; O. The patient has chronic renal insufficiency (serum creatinine \\> 2.5 mg\u002FdL).\n\n* The diameter of the common carotid artery on the target lesion side is \\> 6 mm;\n* The patient is able to understand the purpose of the trial, voluntarily participates in this study, signs the informed consent form, and is willing to complete the follow-up according to the requirements of the protocol.\n\nExclusion Criteria:\n\n* Anatomical exclusion criteria:\n\nThere are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are lesions in the access area of the common carotid artery on the target lesion side and its proximal part towards the heart; The distance from the superior border of the clavicle on the target lesion side to the bifurcation of the common carotid artery is less than 5 cm; A stent or graft has been implanted in the carotid artery on the target lesion side; There are acute or subacute thrombosis, arteriovenous malformations at the target lesion or adjacent areas; Severe calcification or tortuosity at the target lesion site makes it difficult to deliver the instruments to the designated location; The target carotid artery is completely occluded;\n\n* Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);\n* Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);\n* The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;\n* There has been spontaneous intracranial hemorrhage within 12 months;\n* Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);\n* There are other heart diseases that may lead to embolism: such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, artificial aortic valve or artificial mitral valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm or left atrial myxoma, etc.;\n* Severe dementia or other nervous system diseases that may interfere with the evaluation of neurological function;\n* Advanced heart failure;\n* Chronic atrial fibrillation; Paroxysmal atrial fibrillation with an episode within 6 months or paroxysmal atrial fibrillation requiring long-term anticoagulant therapy;\n* Myocardial infarction occurred within 72 hours before the operation;\n* Coronary artery bypass grafting (CABG), endovascular stent surgery, cardiac valve surgery or vascular surgical procedures have been or will be performed within 30 days before and after the operation;\n* There is an active bleeding tendency or severe coagulation dysfunction; There has been gastrointestinal bleeding within 30 days before the operation, which will affect antiplatelet therapy;\n* Hemoglobin (Hgb) \\\u003C 8 gm\u002FdL, platelet count \\\u003C 90×10\\^9\u002FL or a history of heparin-induced thrombocytopenia;\n* Patients with abnormal liver and kidney function before the operation \\[Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Serum creatinine (Cr) \\> 3.0mg\u002FdL (265.2μmol\u002FL) or end-stage renal disease receiving hemodialysis\\];\n* Patients known to be allergic to contrast agents, stent and delivery device materials (referring to nitinol, PTFE, nylon polymer materials); Patients known to have contraindications to anticoagulant and antiplatelet drugs;\n* Intracranial tumors or other malignant tumors;\n* Life expectancy is less than 1 year;\n* Women who plan to become pregnant, are pregnant or are breastfeeding;\n* Patients who are participating in other clinical trials at the same time and have not withdrawn from the trials;\n* Patients who are judged by the researcher as not suitable for participating in this clinical trial.","ALL","18 Years",{"count":19,"type":20},162,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment",[26,27,28],"Revascularization","Carotid Artery Stenosis","Carotid Artery Diseases","RECRUITING","2025-08-04",{"date":32,"type":33},"2025-08-07","ACTUAL",{"date":35,"type":33},"2025-06-30",{"date":37,"type":20},"2025-12-31",{"name":39,"class":40},"Shenzhen Wecan Medical Technology Co.,Ltd","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":41},"100589839","study-on-the-trans-carotid-artery-occlusion-shunt-system-combined-with-introducer-sets-100589839","NCT06959628","Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets","Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients with internal carotid artery stenosis, meeting at least one of the following conditions:\n* Asymptomatic carotid artery stenosis: Stenosis severity \\> 70%;\n* Symptomatic carotid artery stenosis: Stenosis severity \\> 50%, with one or more of the following symptoms occurring within 180 days prior to the procedure: transient ischemic attack (TIA), transient visual obscurations (TVO), or mild\u002Fnon-disabling stroke;\n* Common carotid artery diameter \\> 6 mm, and meets the required vascular diameter for carotid artery stenting;\n* The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as outlined in the study protocol.\n\nExclusion Criteria:\n\n* Anatomical Exclusion Criteria:\n* Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;\n* Patients with lesions in the common carotid artery access area or its proximal segment;\n* Patients with the common carotid artery bifurcation located \\\u003C 5 cm from the clavicular margin;\n* Patients with tandem severe stenosis or occlusion at the target lesion site;\n* Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;\n* Patients with bilateral carotid artery stenosis requiring intervention on both sides;\n* Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;\n* Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;\n* Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;\n* Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;\n* Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;\n* Patients diagnosed with carotid artery dissection;\n* Patients with carotid stenosis due to non-atherosclerotic causes;\n* Patients with other cardiovascular conditions that may predispose to embolism, including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitral valves, infective endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma;\n* Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);\n* Patients with chronic atrial fibrillation;\n* Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;\n* Patients who have had a myocardial infarction within the last 6 months;\n* Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 days prior to the procedure, which may interfere with endpoint evaluation;\n* Patients with active bleeding tendencies or significant coagulation disorders;\n* Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;\n* Patients with preoperative liver or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 times the upper limit of normal, or serum creatinine (Cr) \\> 3.0 mg\u002FdL (265.2 μmol\u002FL);\n* Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);\n* Patients with intracranial or other malignancies;\n* Patients with a life expectancy of less than 3 years;\n* Women who are planning pregnancy, pregnant, or breastfeeding;\n* Patients participating in another clinical trial or those who have not withdrawn or been excluded from a trial within the last 3 months of the screening period;\n* Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study",{"count":50,"type":20},15,[23],"The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty",[27,28],"2025-04-28",{"date":56,"type":33},"2025-05-06",{"date":58,"type":33},"2024-07-01",{"date":60,"type":20},"2025-06-01",{"name":39,"class":40},""]