Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets

Launched by SHENZHEN WECAN MEDICAL TECHNOLOGY CO.,LTD · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the Trans-Carotid Artery Occlusion Shunt System, which is designed to help protect the brain during a procedure called carotid angioplasty. This procedure is often done to treat narrowed carotid arteries, which can lead to serious conditions like strokes. The main goal of the study is to assess how safe and effective this new system is when combined with special introducer sets.

To participate in the trial, individuals need to be at least 18 years old and have a specific type of narrowed carotid artery. For example, those who have severe narrowing (more than 70%) but no symptoms, or those with milder narrowing (more than 50%) who have had recent symptoms like a mini-stroke, may qualify. However, there are some criteria that could exclude potential participants, such as certain health conditions or previous surgeries on the carotid arteries. If someone is eligible and agrees to join, they can expect follow-up care and support throughout the trial. It’s important for all participants to understand the trial's purpose and be willing to comply with the study's requirements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years;
• * Patients with internal carotid artery stenosis, meeting at least one of the following conditions:
• • Asymptomatic carotid artery stenosis: Stenosis severity \> 70%;
• • 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/non-disabling stroke;
• • Common carotid artery diameter \> 6 mm, and meets the required vascular diameter for carotid artery stenting;
• • 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.
• Exclusion Criteria:
• * Anatomical Exclusion Criteria:
• • Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;
• • Patients with lesions in the common carotid artery access area or its proximal segment;
• • Patients with the common carotid artery bifurcation located \< 5 cm from the clavicular margin;
• • Patients with tandem severe stenosis or occlusion at the target lesion site;
• • Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;
• • Patients with bilateral carotid artery stenosis requiring intervention on both sides;
• • Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;
• • Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;
• • Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;
• • Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;
• • Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;
• • Patients diagnosed with carotid artery dissection;
• • Patients with carotid stenosis due to non-atherosclerotic causes;
• • 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;
• • Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);
• • Patients with chronic atrial fibrillation;
• • Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;
• • Patients who have had a myocardial infarction within the last 6 months;
• • 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;
• • Patients with active bleeding tendencies or significant coagulation disorders;
• • Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;
• • 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/dL (265.2 μmol/L);
• • Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);
• • Patients with intracranial or other malignancies;
• • Patients with a life expectancy of less than 3 years;
• • Women who are planning pregnancy, pregnant, or breastfeeding;
• • 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;
• • Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study