Actively Recruiting
A Prospective, Multicenter, Single-Group Clinical Trial of the 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
204 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
Researchers are evaluating the safety and effectiveness of the Lifetech Concave Supra-arch Branched Stent-Graft System for treating aortic arch diseases such as aortic arch aneurysms and penetrating aortic ulcers. This study is designed as a prospective, multicenter, single-group clinical trial to assess this device in patients needing intervention for these conditions, focusing on outcomes related to surgery and long-term vessel health. The study involves the use of the Concave Supra-arch Branched Stent-Graft System for endovascular treatment, where the stent-graft is placed inside the aorta to manage the disease. The procedure targets patients with specific anatomical criteria regarding the aorta and branch vessels. The study includes a detailed monitoring schedule with assessments at surgery, before discharge, and follow-ups at 6 months, 12 months, and up to 5 years to track treatment success and complications. Participants will undergo evaluations including imaging and clinical assessments to monitor technical success, vessel patency, aneurysm size changes, complications like endoleaks or stent migration, adverse events, and mortality related to the aorta and overall health. The study monitors safety closely during the perioperative period and long-term. Participants will be followed for up to five years to assess the outcomes and safety of the device after treatment.
CONDITIONS
Brief 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 ≥ 50 mm (from aortic sinus to anterior edge of innominate artery)
- Proximal main body anchoring diameter between 25-45 mm and length ≥ 30 mm
- Anchored area diameter of supra-arch branch vessels between 5-18 mm, distal anchorage length ≥ 15 mm
- Distance between anterior edge of innominate artery to posterior edge of left subclavian artery ≤ 80 mm
- Suitable iliac, femoral, and superior arch arterial access
- Considered high-risk for surgical treatment or with significant surgical contraindications (EuroSCORE ≥ 6)
- Understands study purpose, consents, and agrees to complete follow-up visits
You will not qualify if you...
- Ruptured or infected aneurysms
- Aortic dissection
- General or local infections increasing endovascular graft infection risk
- Severe stenosis, calcification, or thrombus in the stent anchoring area affecting adherence or patency
- Previous endovascular intervention involving the aortic arch
- Open or endovascular abdominal aorta surgery within past 3 months
- Stroke history within past 3 months (excluding TIA)
- Aneurysms needing reconstruction of important visceral abdominal branch vessels
- Myocardial infarction within past 3 months
- Congestive heart failure NYHA Class IV
- Allergic to contrast agents or stent/delivery system materials
- Contraindications to anticoagulant or antiplatelet drugs
- Unable to tolerate general anesthesia
- Abnormal liver or kidney function before surgery
- Connective tissue diseases like Marfan, Ehlers-Danlos, Behcet's
- 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/exclusion in past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days (pre-discharge period)
Participants undergo endovascular treatment using the Concave Supra-arch Branched Stent-Graft System for Aortic Arch Diseases.
1 surgical procedure and hospital stay up to 14 days
Duration - Up to 5 years postoperatively
Participants are monitored for safety and efficacy outcomes after the procedure including assessments of stent graft function and complications.
Visits at 30 days, 6 months, 12 months, and annually up to 5 years
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
M
Martin Czerny, Professor
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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