Prospective, Multicenter, Single-Arm Study of Aortic Arch... | NCT07139912

NCT07139912

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participant Group/Arm	Experimental	Participants will be treated with Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd	Device: Thoracic Aortic Multi-Branch Stent Graft System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracic Aortic Multi-Branch Stent Graft System	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
12-month treatment success rate	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.	12-month
30-day rate of Major Adverse Events (MAE)	Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure	30-day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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