Actively Recruiting
Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-06-22
46
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.
CONDITIONS
Official Title
Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged greater than 18 years old and less than 80 years old
- Diagnosed with thoraco-abdominal aortic dissecting aneurysm with at least one of the following: maximum aneurysm diameter >50 mm; increase in diameter >5 mm in past 6 months; symptoms like abdominal or back pain related to the aneurysm; poor aneurysm morphology; aortic dissection tears to iliac artery with common iliac artery dissection tumor diameter >40 mm
- Meet anatomical criteria including proximal anchoring area diameter 17-36 mm with length ≥25 mm; distal anchoring area diameter 7-25 mm (iliac artery) or 12-36 mm (abdominal aorta) with respective lengths ≥15 mm or ≥20 mm; normal anchoring areas at distal visceral branch vessels, renal artery, and suitable arterial access
- Understand the trial purpose, volunteer, sign informed consent, and agree to complete follow-up as required
You will not qualify if you...
- Severe hematoma in the aortic wall in the proximal anchoring area of the stent
- Need for simultaneous coverage and embolization of both internal iliac arteries
- History of acute coronary syndrome within 6 months
- Transient ischemic attack or ischemic/hemorrhagic stroke within 3 months
- Severe liver or kidney dysfunction (ALT or AST >5 times normal upper limit; serum creatinine >150 umol/L)
- Severe pulmonary insufficiency preventing general anesthesia
- Severe coagulopathy
- History of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, or stent materials
- Connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease
- Arteritis
- Significant organ dysfunction or serious diseases
- Women who are pregnant, planning pregnancy, or lactating
- Participation in another clinical trial without withdrawal within past 3 months
- Life expectancy less than 1 year
- Investigator judgment deeming patient unsuitable for endovascular treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospita
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Wei Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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