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
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty
Beijing Anzhen Hospital
Beijing, China
RECRUITINGThe 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.
Time frame: Within 30 days after procedure
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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)
All-cause mortality Refers to deaths from any cause that occur within the follow-up time points
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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)
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.
Time frame: Intraoperatively, pre-discharge (up to 14 days) and 30 days post-surgery]