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

NCT06959628 | Recruiting

• 1 other identifier: WKP002FIM(CN)-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carotid Artery Stenosis; Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Immediate technical success rate

  intraoperative

• The incidence of stroke

  pre-discharge (up to 14 days) and 30 days post-surgery

• The incidence of neurological injury

  Within 24 hours post-surgery and 30 days post-surgery

• The incidence of myocardial infarction

  pre-discharge (up to 14 days) and 30 days post-surgery

• All-cause mortality during perioperative period (from surgery to 30 days after surgery)

  Intraoperatively, pre-discharge (up to 14 days) and 30 days post-surgery

Study Arms (1)

Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

EXPERIMENTAL

Device systems for the treatment of carotid artery stenosis

Device: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

Interventions

Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets DEVICE

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

Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.);

Sponsors & Collaborators

• Shenzhen Wecan Medical Technology Co.,Ltd: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• zhong chen, Professor

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhong chen, Professor

CONTACT

18911662898; chenzhong86580@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)