Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction

MicroPort

Status: Not yet enrolling

Conditions: Aortic Arch Disease

Treatments: Device: Thoracic Aortic Multi-Branch Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07139912

Endovastec

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Participant Group/Arm

Experimental group

Description:

Participants will be treated with Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd

Treatment:

Device: Thoracic Aortic Multi-Branch Stent Graft System