NCT06520774 Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases
| NCT ID | NCT06520774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. |
| Condition | Aortic Arch Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 103 participants in total. It began in 2024-05-30 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
chang shu, Professor
PRINCIPAL INVESTIGATOR
Second Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT06520774 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aortic Arch Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06520774 currently recruiting?
Yes, NCT06520774 is actively recruiting participants. Contact the research team at changshu01@yahoo.com for enrollment information.
Where is the NCT06520774 trial being conducted?
This trial is being conducted at Beijing, China, Changsha, China, Chengdu, China, Fuzhou, China and 11 additional locations.
Who is sponsoring the NCT06520774 clinical trial?
NCT06520774 is sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. The principal investigator is chang shu, Professor at Second Xiangya Hospital of Central South University. The trial plans to enroll 103 participants.