Actively Recruiting
Study on the Trans-Carotid Artery Occlusion Shunt System
Led by Shenzhen Wecan Medical Technology Co.,Ltd · Updated on 2025-08-07
162
Participants Needed
1
Research Sites
26 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 for Carotid Artery Revascularization during Endovascular Treatment
CONDITIONS
Official Title
Study on the Trans-Carotid Artery Occlusion Shunt System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosed with carotid artery stenosis and planned for transcarotid artery endovascular revascularization
- For symptomatic stenosis: stenosis over 50% with stroke, TIA, or amaurosis fugax within 180 days
- For asymptomatic stenosis: stenosis over 70% without neurological symptoms within 180 days
- Modified Rankin Scale score of 2 or less before enrollment
- Meets at least one high-risk anatomical or comorbid condition such as contralateral carotid occlusion, tandem stenosis over 70%, carotid stenosis above C2 vertebra, restenosis after previous surgery, bilateral stenosis requiring treatment, difficult neck, age 70 or older, coronary artery disease with angina, severe heart failure, severe lung disease, permanent contralateral cranial nerve injury, or chronic renal insufficiency
- Diameter of the common carotid artery on the target side greater than 6 mm
- Able to understand the study purpose, voluntarily participate, sign consent, and complete follow-up
You will not qualify if you...
- Extensive atherosclerotic plaques in the proximal common carotid artery making surgery unsafe
- Lesions in the access area of the common carotid artery or within 5 cm from clavicle to bifurcation
- Presence of stent or graft in the target carotid artery
- Acute or subacute thrombosis, arteriovenous malformations at or near target
- Severe calcification or tortuosity preventing instrument delivery
- Complete occlusion of target carotid artery
- Uncontrollable hypertension with systolic ≥180 mmHg or diastolic ≥110 mmHg
- Symptomatic severe stenosis of other vessels
- Ischemic stroke within 3 months affecting endpoint evaluation
- Spontaneous intracranial hemorrhage within 12 months
- Carotid stenosis not caused by atherosclerosis
- Other heart diseases that may cause embolism, such as valve disorders or cardiomyopathies
- Severe dementia or neurological diseases interfering with evaluation
- Advanced heart failure
- Chronic or recent paroxysmal atrial fibrillation requiring long-term anticoagulation
- Myocardial infarction within 72 hours before operation
- Recent major cardiac or vascular surgery within 30 days before or after operation
- Active bleeding or severe coagulation disorders
- Recent gastrointestinal bleeding affecting antiplatelet therapy
- Low hemoglobin or platelet counts or history of heparin-induced thrombocytopenia
- Severe liver or kidney dysfunction or end-stage renal disease on dialysis
- Allergies to contrast agents, stent materials, or contraindications to anticoagulants
- Intracranial or other malignant tumors
- Life expectancy less than 1 year
- Women who are pregnant, breastfeeding, or planning pregnancy
- Participation in other clinical trials without withdrawal
- Judged unsuitable by the researcher for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Z
zhong chen, Professor
CONTACT
W
Wei zhang, 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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