Actively Recruiting
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2025-07-28
103
Participants Needed
17
Research Sites
369 weeks
Total Duration
On this page
Sponsors
L
Lifetech Scientific (Shenzhen) Co., Ltd.
Lead Sponsor
S
Second Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
CONDITIONS
Official Title
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years inclusive
- Diagnosed with aortic arch aneurysms or penetrating ulcers requiring intervention with proximal stent anchoring in the Z0 zone
- Ascending aorta length of at least 50 mm from aortic sinus to innominate artery edge
- Diameter of proximal anchoring area between 25-45 mm and length at least 30 mm
- Diameter of supra-arch branch vessels between 5-18 mm with distal anchorage length at least 15 mm
- Distance between innominate artery front edge and left subclavian artery back edge no more than 80 mm
- Suitable iliac, femoral, and superior arch arterial access
- Considered high-risk for surgery or with significant contraindications by at least two researchers, recommended EuroSCORE ≥6
- Understands the study purpose, volunteers, signs informed consent, and agrees to follow-up visits
You will not qualify if you...
- Ruptured or infected aneurysms
- Aortic dissection
- General or local infections increasing risk of graft infection
- Severe stenosis, calcification, or thrombus in stent anchoring area affecting device adherence or patency
- Previous endovascular intervention involving the aortic arch
- Open or endovascular abdominal aorta surgery within past 3 months
- Stroke within past 3 months (excluding TIA)
- Aneurysms involving distal descending aorta requiring visceral branch reconstruction
- Myocardial infarction within past 3 months
- Congestive heart failure NYHA Class IV
- Allergies to contrast agents or stent materials
- Contraindications to anticoagulant or antiplatelet drugs
- Unable to tolerate general anesthesia
- Abnormal liver/kidney function before surgery (ALT/AST >5x normal, serum creatinine >150 umol/L)
- Connective tissue diseases (Marfan syndrome, Ehlers-Danlos syndrome, Behcet's disease)
- Arteritis
- Life expectancy less than 1 year
- Women planning pregnancy, pregnant, or breastfeeding
- Deemed unsuitable for endovascular treatment by investigator
- Participation in other clinical studies without withdrawal or exclusion within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Second Xiangya Hospital of Central South University
Changsha, China
Actively Recruiting
3
West China Hospital, Sichuan University
Chengdu, China
Actively Recruiting
4
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Actively Recruiting
5
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Actively Recruiting
6
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
Actively Recruiting
7
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Actively Recruiting
8
The First People's Hospital of Yunnan Province
Kunming, China
Actively Recruiting
9
Yunnan Fuwai Cardiovascular Disease Hospital
Kunming, China
Actively Recruiting
10
Jiangsu Provincial People's Hospital
Nanjing, China
Actively Recruiting
11
Nanjing First Hospital
Nanjing, China
Actively Recruiting
12
Zhongshan Hospital of Fudan University
Shanghai, China
Actively Recruiting
13
Shenzhen Hospital of Fuwai Hospital of Chinese Academy of Medical Sciences
Shenzhen, China
Actively Recruiting
14
Renmin Hospital of Wuhan University
Wuhan, China
Actively Recruiting
15
Cardiovascular Disease Hospital Affiliated to Xiamen University
Xiamen, China
Actively Recruiting
16
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
17
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany
Not Yet Recruiting
Research Team
C
chang shu, Professor
CONTACT
M
Martin Czerny, 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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