Study on the Trans-Carotid Artery Occlusion Shunt System
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 for Carotid Artery Revascularization during Endovascular Treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years;
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.
Disqualifiers
Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);
Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);
The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;
There has been spontaneous intracranial hemorrhage within 12 months;
Trial design
Design model
Single group
Treatments tested in this trial
Trans-Carotid Artery Occlusion Shunt System
DeviceTo evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System for Carotid Artery Revascularization during Endovascular Treatment
Treatment groups
162 Participants
are divided into 1 treatment groupGroup A: Trans-Carotid Artery Occlusion Shunt SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The composite incidence rate of death, stroke, and myocardial infarction within 30 days after the operation.
The composite incidence rate of death, stroke, and myocardial infarction.
Time frame
30 days after the operationSecondary outcomes
1
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.
Time frame
Immediate technical success rate2
Surgical success rate
Surgical success is defined as technical success without major adverse events (MAE is defined as death, stroke, or myocardial infarction).
Time frame
30 days after the operation3
Incidence rate of stroke within 30 days after the operation
The researcher will confirm whether the subject has suffered a stroke.
Time frame
30 days after the operation4
Incidence rate of cranial nerve injury within 30 days after the operation
The researcher will confirm whether the subject has suffered a cranial nerve injury.
Time frame
30 days after the operationSponsors and contacts
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Source ClinicalTrials.gov