Actively Recruiting
Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
Led by Shenzhen Wecan Medical Technology Co.,Ltd · Updated on 2025-05-06
15
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with internal carotid artery stenosis meeting one of these: asymptomatic stenosis greater than 70%, or symptomatic stenosis greater than 50% with symptoms like transient ischemic attack, transient visual obscurations, or mild stroke within 180 days before procedure
- Common carotid artery diameter greater than 6 mm and suitable for carotid artery stenting
- Able to understand the study, provide informed consent, and comply with follow-up requirements
You will not qualify if you...
- Extensive atherosclerotic plaques in the proximal common carotid artery preventing safe surgery
- Lesions in the common carotid artery access area or its proximal segment
- Common carotid artery bifurcation less than 5 cm from the clavicular margin
- Severe stenosis or occlusion at the target lesion site
- Previous stent or graft implantation in the same carotid artery
- Bilateral carotid artery stenosis needing treatment on both sides
- Acute or subacute thrombosis, arteriovenous malformations, or abnormal vessels near target lesion
- Severe calcification or tortuosity at target lesion making device delivery difficult
- Severe symptomatic stenosis in other brain or neck arteries
- Ischemic stroke within past 3 months
- History of spontaneous intracranial hemorrhage within past 12 months
- Carotid artery dissection
- Carotid stenosis from non-atherosclerotic causes
- Other heart conditions that increase embolism risk
- Central nervous system disorders affecting evaluation
- Chronic or recent atrial fibrillation requiring long-term anticoagulation
- Myocardial infarction within 6 months
- Recent or planned heart surgeries or interventions within 90 days
- Active bleeding or significant clotting disorders
- History of gastrointestinal bleeding affecting antiplatelet therapy
- Liver or kidney dysfunction beyond specified limits
- Allergy to contrast agents, anticoagulants, antiplatelet drugs, or device materials
- Intracranial or other cancers
- Life expectancy under 3 years
- Women pregnant, planning pregnancy, or breastfeeding
- Participation in another clinical trial within past 3 months
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, China
Actively Recruiting
Research Team
Z
zhong chen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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