Endovascular treatment for aortic arch diseases using a new stent-graft system

A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases

This study is testing a new stent-graft system to see if it can safely and effectively treat aortic arch diseases like aneurysms and ulcers in patients aged 18 to 80.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 17 sites (Beijing and 16 other locations)
• Trial ID: NCT06520774 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Lifetech Concave Supra-arch Branched Stent-Graft System for treating aortic arch diseases, specifically aortic arch aneurysms and penetrating aortic ulcers. Patients aged 18 to 80 who meet specific anatomical criteria will receive the stent-graft as part of the intervention. The study protocol requires strict adherence, with provisions for emergency situations where immediate action is necessary. The outcomes will be monitored to assess the device's performance and patient safety.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 80 with aortic arch aneurysms or penetrating ulcers requiring intervention and meeting specific anatomical criteria.

Not a fit: Patients with conditions that do not meet the anatomical requirements for the stent-graft or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for patients with serious aortic arch conditions, potentially improving recovery times and outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in endovascular treatments for aortic conditions, suggesting potential for success.

Eligibility criteria

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.

Where this trial is running

Beijing and 16 other locations

• 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)

Study contacts

• Principal investigator: chang shu, Professor — Second Xiangya Hospital of Central South University
• Study coordinator: chang shu, Professor

Conditions Aortic Arch Aneurysm; Penetrating Aortic Ulcer; Lifetech; Concave Supra-arch Branched Stent-Graft System; Endovascular Treatment