Aortic Arch Disease
Conditions
Brief summary
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies.
Interventions
DEVICEThoracic Aortic Multi-Branch Stent Graft System
The Thoracic Aortic Multi-Branch Stent Graft Systemm consists of the Single-Branch Aortic Stent-Graft System, the aortic extension stent graft system and the branch stent system.
Sponsors
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 80 years 2. Diagnosed with aortic arch pathology requiring intervention, including: True aortic arch aneurysm Pseudoaneurysm of the aortic arch Penetrating aortic ulcer involving the arch 3. Deemed suitable for endovascular repair by the investigating physician 4. Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements 5. Anatomic suitability confirmed by CTA: Ascending aortic length ≥50 mm Ascending aortic diameter ≥26 mm and ≤46 mm Proximal landing zone length ≥20 mm Brachiocephalic trunk diameter ≥9 mm and ≤19 mm with length ≥20 mm Left common carotid artery (LCCA) and left subclavian artery (LSA) diameters ≥5 mm and ≤13 mm LCCA length ≥20 mm Distance from LSA ostium to left vertebral artery origin ≥20 mm 6. High surgical risk per investigator assessment OR contraindicated for open surgery
Exclusion criteria
1. Pregnant or lactating women 2. Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome) 3. Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis) 4. Prior endovascular repair of ascending aorta/aortic arch 5. Documented allergy to nitinol, contrast media, or device materials 6. Severe renal impairment:(Serum creatinine \>2×ULN,Excluding dialysis-dependent patients) 7. Hematologic abnormalities:(WBC \<3×10⁹/L、Hb \<70 g/L、PLT \<50×10⁹/L) 8. Heart transplant recipients 9. Myocardial infarction or stroke within 3 months 10. NYHA Class IV heart failure 11. Active systemic infection (e.g., bacteremia, sepsis) 12. Life expectancy \<12 months 13. Mechanical aortic valve prosthesis impeding device delivery 14. Current participation in other interventional trials with primary endpoint pending 15. Anticipated poor compliance with follow-up 16. Other contraindications for endovascular repair per investigator assessment:Severe vascular stenosis/calcification/tortuosity/Thrombus at landing zones/Inability to cooperate with procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month treatment success rate | 12-month | Technical success at the index procedure, without device- or aortic pathology-related mortality or unplanned secondary interventions, and with no evidence of persistent enlargement of the treated aortic segment due to Type I/III endoleaks on 12-month CTA follow-up. |
| 30-day rate of Major Adverse Events (MAE) | 30-day | Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure |
Countries
China
Contacts
Primary ContactQingsheng Lu
Outcome results
None listed