Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic Aortic Multi-Branch Stent Graft System.
- Who it may be relevant to
- Registry conditions: Aortic Arch Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective, Multicenter, Single-Arm Trial Assessing Safety/Effectiveness of Multi-Branch Thoracic Stent Grafts in Aortic Arch Disease
Overview
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
- Device Thoracic 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.
Primary outcome measures
- 12-month treatment success rate [Time frame: 12-month]
- 30-day rate of Major Adverse Events (MAE) [Time frame: 30-day]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Changhai Hospital — Shanghai
Identifiers
NCT: NCT07139912 · Endovastec