Concave Supra-arch Branched Stent-Graft System: To evaluate the efficacy and safety of Concave Supra-arch Branched Stent-Graft System for endovascular treatment of Aortic Arch Diseases
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients who are aged 18 to 80 years inclusive;
2. Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;
3. Anatomical criteria, including:
1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);
2. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;
3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;
4. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;
5. Have a suitable iliac, femoral, and superior arch arterial access;
4. At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;
5. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.
Exclusion Criteria:
1. Patients either with ruptured or infected aneurysms;
2. Patients with aortic dissection;
3. Patients with general or local infections that may increase the risk of endovascular graft infection;
4. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;
5. Previous endovascular intervention involving the aortic arch;
6. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;
7. Patients with a history of stroke within the past 3 months (excluding TIA);
8. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;
9. Patients with a history of myocardial infarction within the past 3 months;
10. Patients with congestive heart failure - NYHA Class IV;
11. Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);
12. Patients with contraindications to anticoagulant or antiplatelet drugs;
13. Patients unable to tolerate general anesthesia;
14. Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) \>150umol/L);
15. Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;
16. Patients with arteritis;
17. Patients with a life expectancy of less than 1 year;
18. Women who are planning to conceive, pregnant or breastfeeding;
19. Patients deemed by the investigator as unsuitable for endovascular treatment;
20. Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.
Primary outcome measure(s)
Incidence of composite endpoints — within 30 days post-surgery Composite endpoints refer to the occurrence of any of the following within 30 days post-surgery: all-cause mortality, disabling stroke, or permanent paraplegia.
The clinical treatment success rate within 12 months — pre-discharge (up to 14 days) and 12 months postoperatively The 12-month clinical treatment success rate is a composite endpoint that includes immediate technical success after surgery and the absence of the following conditions at 12 months postoperatively: death, displacement of the aortic or branch covered stents on CTA follow-up, Type I or III endoleak, branch stent occlusion, and the need for secondary surgical intervention during the follow-up period.
Trial sites (17)
Facility
City
Region
Status
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
China
Recruiting
Second Xiangya Hospital of Central South University
Changsha
China
Recruiting
West China Hospital, Sichuan University
Chengdu
China
Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
China
Recruiting
Union Hospital Affiliated to Fujian Medical University
Fuzhou
China
Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou
China
Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming
China
Recruiting
The First People's Hospital of Yunnan Province
Kunming
China
Recruiting
Yunnan Fuwai Cardiovascular Disease Hospital
Kunming
China
Recruiting
Jiangsu Provincial People's Hospital
Nanjing
China
Recruiting
Nanjing First Hospital
Nanjing
China
Recruiting
Zhongshan Hospital of Fudan University
Shanghai
China
Recruiting
Shenzhen Hospital of Fuwai Hospital of Chinese Academy of Medical Sciences
Shenzhen
China
Recruiting
Renmin Hospital of Wuhan University
Wuhan
China
Recruiting
Cardiovascular Disease Hospital Affiliated to Xiamen University
Xiamen
China
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
China
Recruiting
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau
Germany
Not Yet Recruiting
More Lifetech Scientific (Shenzhen) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.