About this trial
The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
Male or female ≥18 years old, ≤85 years old;
Life expectancy > 2 years;
The patient signed the informed consent voluntarily and was able to comply with the treatment plan and complete the follow-up and examination as planned.
Disqualifiers
Fungal or ruptured aneurysm
Known complications of thoracic aortic aneurysm require interventional treatment
American Association of Anesthesiologists (ASA) Grade V
Creatinine > 2.5mg/dL or dialysis patients
Trial population
Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents
Trial design
Cohort
Prospective
Treatments tested in this trial
IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company
DevicePatients underwent endovascular treatment for reconstruction of internal iliac artery in abdominal aortic aneurysm/iliac aneurysm repair. The lesion will be treated by IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore Company.
Treatment groups
Trial outcomes
Primary outcomes
Primary patency
CTA showed patency of the preserved internal iliac artery.
Secondary outcomes
New hip lameness
New hip lameness is defined as new hip claudication in the lateral body treated with an iliac artery branch stent.
Internal leakage
Internal leakage is defined as any type of internal leakage that occurs during the follow-up period.
Aneurysmal enlargement
Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery.
Aneurysm rupture
Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up.
Sponsors and contacts
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