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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai MicroPort Endovascular MedTech(Group)Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 to 80 years

Deemed suitable for endovascular repair by the investigating physician

Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements

High surgical risk per investigator assessment OR contraindicated for open surgery

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Thoracic Aortic Multi-Branch Stent Graft System

Treatment groups

96 Participants
are divided into 1 treatment group