Status:
NOT_YET_RECRUITING
Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction
Lead Sponsor:
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Conditions:
Aortic Arch Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years
- Diagnosed with aortic arch pathology requiring intervention, including:
- True aortic arch aneurysm
- Pseudoaneurysm of the aortic arch
- Penetrating aortic ulcer involving the arch
- Deemed suitable for endovascular repair by the investigating physician
- Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements
- 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
- High surgical risk per investigator assessment OR contraindicated for open surgery
Exclusion
- Pregnant or lactating women
- Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome)
- Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis)
- Prior endovascular repair of ascending aorta/aortic arch
- Documented allergy to nitinol, contrast media, or device materials
- Severe renal impairment:(Serum creatinine \>2×ULN,Excluding dialysis-dependent patients)
- Hematologic abnormalities:(WBC \<3×10⁹/L、Hb \<70 g/L、PLT \<50×10⁹/L)
- Heart transplant recipients
- Myocardial infarction or stroke within 3 months
- NYHA Class IV heart failure
- Active systemic infection (e.g., bacteremia, sepsis)
- Life expectancy \<12 months
- Mechanical aortic valve prosthesis impeding device delivery
- Current participation in other interventional trials with primary endpoint pending
- Anticipated poor compliance with follow-up
- Other contraindications for endovascular repair per investigator assessment:Severe vascular stenosis/calcification/tortuosity/Thrombus at landing zones/Inability to cooperate with procedure
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07139912
Start Date
September 1 2025
End Date
March 1 2032
Last Update
August 24 2025
Active Locations (1)
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1
Changhai Hospital
Shanghai, China