Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Wecan Medical Technology Co.,Ltd
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years;
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets
DeviceTo evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Trans-Carotid Artery Occlusion Shunt System Combined with Introducer SetsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Within 30 days after procedureSecondary outcomes
1
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
intraoperative2
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-surgery3
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-surgery4
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-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov