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
Qualifiers
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
Treatments tested in this trial
- Trans-Carotid Artery Occlusion Shunt System
Treatment groups
162 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov