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

Official title

Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets for Cerebral Protection During Carotid Angioplasty

Overview

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

Detailed description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee

Interventions

• Device Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets
  To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty

Primary outcome measures

• The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively. [Time frame: Within 30 days after procedure]

Secondary outcome measures (6)

• Immediate technical success rate [Time frame: intraoperative]
• The incidence of stroke [Time frame: pre-discharge (up to 14 days) and 30 days post-surgery]
• The incidence of neurological injury [Time frame: Within 24 hours post-surgery and 30 days post-surgery]
• The incidence of myocardial infarction [Time frame: pre-discharge (up to 14 days) and 30 days post-surgery]
• All-cause mortality during perioperative period (from surgery to 30 days after surgery) [Time frame: Intraoperatively, pre-discharge (up to 14 days) and 30 days post-surgery]
• Delivery system-related complications during perioperative period (from surgery to 30 days after surgery) [Time frame: Intraoperatively, pre-discharge (up to 14 days) and 30 days post-surgery]]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

China · 1 center

• Beijing Anzhen Hospital — Beijing

Identifiers

NCT: NCT06959628 · WKP002FIM(CN)-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗