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

NCT ID: NCT07139912

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2032-03-31

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.

Conditions

Aortic Arch Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant Group/Arm

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

Group Type: EXPERIMENTAL

Thoracic Aortic Multi-Branch Stent Graft System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Changhai Hospital

Shanghai, , China

Countries

China

Central Contacts

Qingsheng Lu

Role: CONTACT

luqs@newvascular.cn

021-31162185

Facility Contacts

Doctor Lu

Role: primary

luqs@xueguan.net

+86 0213112185

Other Identifiers

Endovastec

Identifier Type: -

Identifier Source: org_study_id