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

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

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases; Carotid Artery Stenosis
• Intervention / Treatment: Device: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zhong chen, Professor; Phone Number: 18911662898; Email: chenzhong86580@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital
    • Contact: zhong chen, Professor; Phone Number: 18911662898; Email: chenzhong86580@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets; Device systems for the treatment of carotid artery stenosis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively.	Composite incidence is the rate of occurrence of a composite endpoint, which is a combination of multiple study outcomes.	Within 30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate technical success rate	Immediate technical success is defined as the complete proximal occlusion of the common carotid artery, successful establishment of an effective retrograde blood flow pathway, and the successful reconstruction of carotid blood circulation.	intraoperative
The incidence of stroke	The incidence of stroke refers to the occurrence of stroke within the follow-up time points, including hemorrhagic and ischemic strokes.	pre-discharge (up to 14 days) and 30 days post-surgery
The incidence of neurological injury	The incidence of neurological injury refers to the occurrence of neurological dysfunction within the follow-up time points, including assessment of swallowing disorders, voice disorders, and facial expression muscle impairment	Within 24 hours post-surgery and 30 days post-surgery
The incidence of myocardial infarction	The incidence of myocardial infarction refers to deaths from any cause that occur within the follow-up time points.	pre-discharge (up to 14 days) and 30 days post-surgery
All-cause mortality during perioperative period (from surgery to 30 days after surgery)	All-cause mortality Refers to deaths from any cause that occur within the follow-up time points	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)	Access-related complications refer to bleeding, rebleeding, and hematoma along the delivery access route. Hematomas include surgical wound hematoma, arterial access site hematoma, and femoral venous access site hematoma.	Intraoperatively, pre-discharge (up to 14 days) and 30 days post-surgery]

Collaborators and Investigators

• Sponsor: Shenzhen Wecan Medical Technology Co.,Ltd
• Investigators: Principal Investigator: zhong chen, Professor, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 28, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Estimated): May 6, 2025

Study Record Updates

• Last Update Posted (Estimated): May 6, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: WKP002FIM(CN)-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No