Recruiting
Not applicable
Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
Condition(s) studied
Aortic Arch AneurysmPenetrating Aortic Ulcer
Investigational drug(s) / intervention(s)
Concave Supra-arch Branched Stent-Graft System
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
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 |
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