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