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

NCT07139912 | Not Yet Recruiting

• 1 other identifier: Endovastec
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

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.

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd: lead

Study Sites (1)

Changhai Hospital

Shanghai, China

Location

Central Study Contacts

Qingsheng Lu

CONTACT

021-31162185; luqs@newvascular.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2032
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)