Actively Recruiting
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
Led by Hangzhou Endonom Medtech Co., Ltd. · Updated on 2026-05-01
90
Participants Needed
20
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)
CONDITIONS
Official Title
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years old
- Diagnosed with aortic arch lesions requiring intervention, including true or pseudo aortic arch aneurysms and ulcers involving the aortic arch
- Suitable vascular condition including ascending aorta length greater than 50 mm and diameter between 24 mm and 48 mm
- Proximal anchoring zone length of at least 30 mm
- Branch arteries to be reconstructed with diameter between 6 mm and 24 mm and length at least 20 mm
- Suitable arterial access for endovascular treatment
- Able to understand the trial purpose, voluntarily consent, and willing to complete follow-up visits
- Assessed as high risk for surgery by at least two investigators or with significant surgical contraindications, such as a EuroScore of 6 or higher
You will not qualify if you...
- Experienced systemic infection during the past three months
- Neck surgery within the last 3 months
- Previous endovascular treatment involving the aortic arch
- Infectious aortic disease, Takayasu arteritis, Marfan syndrome, or other connective tissue diseases
- Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed
- History of heart transplant
- Myocardial infarction or stroke within the past three months
- Class IV heart function according to NYHA classification
- Active peptic ulcers or upper gastrointestinal bleeding within the previous three months
- Hematological abnormalities such as leukopenia, acute anemia, coagulation disorders, or thrombocytopenia
- Renal insufficiency with creatinine over 150 umol/L or end-stage renal disease requiring dialysis
- Pregnant or breastfeeding
- Allergies to contrast agents
- Life expectancy less than 12 months
- Currently participating in another drug or device research
- Any other condition that may hinder endovascular treatment as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Actively Recruiting
2
Chinese PLA Gencral Hosptial
Beijing, China
Actively Recruiting
3
The First Hospital of Jilin University
Changchun, China
Actively Recruiting
4
Xiangya Hospital of Central South University
Changsha, China
Actively Recruiting
5
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
6
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, China
Actively Recruiting
7
The First Affiliated Hospital ,Sun Yat-sen University
Guangzhou, China
Actively Recruiting
8
The First Affiliated Hospital of Harbin Medical University
Harbin, China
Actively Recruiting
9
Shandong Provincial Hospital
Jinan, China
Actively Recruiting
10
The First People's Hospital of Yunnan Province
Kunming, China
Actively Recruiting
11
The Second Affiliated Hospital Of Nanchang University
Nanchang, China
Actively Recruiting
12
Nanjing First Hospital
Nanjing, China
Actively Recruiting
13
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China
Actively Recruiting
14
The Affiliated Hospital Of Qingdao University
Qingdao, China
Actively Recruiting
15
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
16
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
17
The First Affiliated Hospital of China Medical University
Shenyang, China
Actively Recruiting
18
The First Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, China
Actively Recruiting
19
Xiamen Cardiovascular Hospital
Xiamen, China
Actively Recruiting
20
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
W
Wei Guo
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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