Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07139912

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

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

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicenter, Single-Arm Trial Assessing Safety/Effectiveness of Multi-Branch Thoracic Stent Grafts in Aortic Arch Disease

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09

Completion Date

2032-03

Last Updated

2025-08-24

Healthy Volunteers

Conditions

Aortic Arch Disease

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.

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

Locations (1)

Changhai Hospital

Shanghai, China