Actively Recruiting
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Led by Hangzhou Endonom Medtech Co., Ltd. · Updated on 2024-05-22
20
Participants Needed
3
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting aneurysm of descending thoracic aorta after aortic dissection repair.
CONDITIONS
Official Title
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years old, any gender
- Diagnosed with dissecting aneurysm of descending thoracic aorta after main artery dissection repair
- Treatment indication includes aortic dissection aneurysm diameter 5.5 cm or larger, or rapid diameter increase of 5 mm or more per year
- Symptoms related to dissection progression such as chest and back pain
- False lumen diameter approximately 1 cm above the celiac trunk is 40 mm or less
- Suitable anatomy for the adjustable bend conveyor to enter pseudolumen through tears in iliac artery, subrenal aorta, or renal artery
- Ability to understand study purpose, voluntarily consent, and willing to complete follow-up
You will not qualify if you...
- Aortic rupture
- Continuous malperfusion of internal artery branches due to dissection
- Previous false lumen embolization treatment
- Proximal type I endoleak after aortic repair
- Abdominal aortic dissection aneurysm diameter over 5 cm
- Infectious aortic disease, arteritis, Marfan syndrome, or other connective tissue diseases
- Acute systemic infection
- History of myocardial infarction, transient ischemic attack, or cerebral infarction within past 3 months
- Cardiac function Grade IV (NYHA) or left ventricular ejection fraction below 30%
- Blood disorders including leukopenia, anemia, coagulation problems, or thrombocytopenia
- Renal insufficiency with serum creatinine over 150 umol/L or advanced kidney disease requiring dialysis
- Severe liver insufficiency with elevated liver enzymes or bilirubin
- Allergies to contrast agents, anesthetics, plugs, or delivery materials
- Pregnancy, breastfeeding, or inability to use contraception during the trial
- Participation in other drug or device clinical trials during the same period
- Life expectancy under 12 months due to conditions like advanced cancers
- Investigator judgment that patient is unsuitable for interventional treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality, China
Actively Recruiting
2
The People's Hospital of Gaozhou
Gaozhou, Guangdong, China
Actively Recruiting
3
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wei Guo, Professor
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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