Actively Recruiting
Study on the Aortic Arch Single Branch Stent Graft System
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-06-11
135
Participants Needed
1
Research Sites
321 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 Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
CONDITIONS
Official Title
Study on the Aortic Arch Single Branch Stent Graft System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, any gender
- Diagnosed with Stanford Type B aortic dissection needing left subclavian artery revascularization
- Proximal aortic landing zone diameter between 20 and 42 mm
- Proximal aortic landing zone length of at least 15 mm
- Distance between left common carotid artery and left subclavian artery at least 5 mm
- Left subclavian artery landing zone length of at least 25 mm and diameter between 5 and 15 mm
- Suitable access to femoral, iliac, and upper limb arteries
- Willingness to participate and complete follow-up visits as required
You will not qualify if you...
- Previous endovascular treatment or surgical repair involving the aortic arch affecting stent evaluation
- Severe stenosis, calcification, or thrombus in stent anchoring area preventing proper stent adherence
- Infectious aortic diseases, giant cell arteritis, Marfan syndrome, or other hereditary connective tissue diseases
- Systemic or local infections increasing risk of graft infection
- Abdominal aortic surgery or endovascular intervention within past 3 months
- Stroke (excluding TIA) or myocardial infarction within past 3 months
- Known allergy to contrast agents or stent and delivery device materials
- Contraindications to anticoagulant or antiplatelet drugs
- Intolerance to general anesthesia
- Severe liver, kidney, or cardiac dysfunction before operation (specific lab value thresholds)
- Expected lifespan under 1 year
- Female patients planning pregnancy, pregnant, or breastfeeding
- Judged unsuitable for endovascular treatment by researcher
- Participation in other clinical studies without withdrawal within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Xiangya Hospital of Central South University
Changsha, China
Actively Recruiting
Research Team
C
chang shu, 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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