Study on the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization During Endovascular Treatment

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years;

• For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:

‣ 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/or amaurosis fugax within 180 days before the operation.

⁃ 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.

• The modified Rankin Scale (mRs) score ≤ 2 before enrollment.

• 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:

∙ Anatomical high-risk:

∙ A. 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.

∙ Comorbid high-risk:

∙ G. 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) \< 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) \< 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/dL).

• The diameter of the common carotid artery on the target lesion side is \> 6 mm;

• 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.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
zhong chen, Professor
chenzhong86580@vip.sina.com
18911662898
Backup
Wei zhang, Professor
weiz36@hotmail.com
18529290566
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 162
Treatments
Experimental: Trans-Carotid Artery Occlusion Shunt System
Device systems for Carotid Artery Revascularization during Endovascular Treatment
Related Therapeutic Areas
Sponsors
Leads: Shenzhen Wecan Medical Technology Co.,Ltd

This content was sourced from clinicaltrials.gov