Carotid Artery Diseases, Carotid Artery Stenosis, Revascularization
Conditions
Brief 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
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
DEVICETrans-Carotid Artery Occlusion Shunt System
To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
Sponsors
Shenzhen Wecan Medical Technology Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. 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. 2. 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.
Exclusion criteria
* Anatomical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite incidence rate of death, stroke, and myocardial infarction within 30 days after the operation. | 30 days after the operation | The composite incidence rate of death, stroke, and myocardial infarction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical success rate | 30 days after the operation | Surgical success is defined as technical success without major adverse events (MAE is defined as death, stroke, or myocardial infarction). |
| Incidence rate of stroke within 30 days after the operation | 30 days after the operation | The researcher will confirm whether the subject has suffered a stroke. |
| Incidence rate of cranial nerve injury within 30 days after the operation | 30 days after the operation | The researcher will confirm whether the subject has suffered a cranial nerve injury. |
| Incidence rate of myocardial infarction within 30 days after the operation | 30 days after the operation | The researcher will confirm whether the subject has suffered a myocardial infarction. |
| Immediate technical success rate | Immediate technical success rate | Immediate technical success is defined as complete occlusion of the proximal common carotid artery, effectively establishing a blood flow reversal circulation pathway, and successfully withdrawing the device. |
| Incidence rate of access complications within 30 days after the operation | 30 days after the operation | Access complications refer to various adverse situations or complications that occur during or after the establishment of vascular accesses. |
| Incidence rate of ipsilateral stroke within 30 days after the operation | 30 days after the operation | The researcher will confirm whether the subject has suffered a ipsilateral stroke. |
| Device-related adverse events | Before discharge (up to 14 days), 30 days after the operation | Adverse events refer to adverse medical events that occur during the process of a clinical trial, regardless of whether they are related to the medical device used in the trial. However, normal postoperative stress responses should be distinguished, such as fever, discomfort in the chest and back, etc. If, upon the judgment of the researcher, it is determined to be a normal postoperative stress response, there is no need to record it as an adverse event of the medical device. Adverse events related to the medical device refer to situations that are determined by the researcher to be definitely related, possibly related, or undeterminable in relation to the medical device used in the trial. |
| Incidence rate of serious adverse events | Before discharge (up to 14 days), 30 days after the operation | Serious adverse events refer to events that occur during the clinical trial process and lead to death or a serious deterioration of health status, including fatal diseases or injuries, permanent defects in body structure or body function, the need for hospitalization or an extended hospital stay, the need to take medical measures to avoid permanent defects in body structure or body function, and events that lead to fetal distress, fetal death, or congenital abnormalities and congenital defects. |
| All-cause mortality rate within 30 days after the operation | 30 days after the operation | All-cause mortality refers to deaths from any cause that occur within the follow-up time points. |
Countries
China
Contacts
Primary Contactzhong chen, Professor
Backup ContactWei zhang, Professor
Outcome results
None listed