Status:
RECRUITING
Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
Lead Sponsor:
Shenzhen Wecan Medical Technology Co.,Ltd
Conditions:
Carotid Artery Stenosis
Carotid Artery Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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, w...
Eligibility Criteria
Inclusion
- 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
- Anatomical
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06959628
Start Date
July 1 2024
End Date
June 1 2025
Last Update
May 6 2025
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, China