Carotid Artery Diseases, Carotid Artery Stenosis
Conditions
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
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
To evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty
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; * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The composite incidence of death, stroke, and myocardial infarction within 30 days postoperatively. | Within 30 days after procedure | Composite incidence is the rate of occurrence of a composite endpoint, which is a combination of multiple study outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of stroke | pre-discharge (up to 14 days) and 30 days post-surgery | The incidence of stroke refers to the occurrence of stroke within the follow-up time points, including hemorrhagic and ischemic strokes. |
| The incidence of neurological injury | Within 24 hours post-surgery and 30 days post-surgery | 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 |
| Immediate technical success rate | intraoperative | 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. |
| 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 | All-cause mortality Refers to deaths from any cause that occur within the follow-up time points |
| Delivery system-related complications during perioperative period (from surgery to 30 days after surgery) | Intraoperatively, pre-discharge (up to 14 days) and 30 days post-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. |
| The incidence of myocardial infarction | pre-discharge (up to 14 days) and 30 days post-surgery | The incidence of myocardial infarction refers to deaths from any cause that occur within the follow-up time points. |
Countries
China
Contacts
Primary Contactzhong chen, Professor
Outcome results
None listed