Aortic Aneurysm, Abdominal, Iliac Aneurysm
Conditions
Keywords
Iliac artery branch stent, Patency rate, Internal iliac artery
Brief summary
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
Detailed description
This study is a prospective observational exploratory cohort study without a control group. As a single-group target value validation study, the main evaluation indicator is the primary patency rate one year after surgery. As an exploratory study, considering the enrollment ability to facilitate data analysis, 40 subjects are enrolled in the final study, and 20 are expected to be included in each study. All enrolled patients will be followed for 12 months for CTA to assess primary patency. Telephone follow-up was conducted at 1, 3, 6, and 12 months for adverse events.
Interventions
DEVICEIBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company
Patients 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.
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents; 2. Male or female ≥18 years old, ≤85 years old; 3. Life expectancy \> 2 years; 4. 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.
Exclusion criteria
1. Fungal or ruptured aneurysm 2. Known complications of thoracic aortic aneurysm require interventional treatment 3. American Association of Anesthesiologists (ASA) Grade V 4. Creatinine \> 2.5mg/dL or dialysis patients 5. NYHA Grade IV heart failure 6. Intercalation, severe calcification, or anchoring area with thrombosis 7. Severe curvature or narrowing of the iliac and/or femoral arteries, resulting in difficulty in stent delivery 8. Conduct another device or drug study within 1 year of treatment 9. Systemic infection 10. Combined with connective tissue disease 11. Known history of drug use 12. Known allergies or allergies to equipment materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12-month | CTA showed patency of the preserved internal iliac artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm rupture | 12-month | Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up. |
| New hip lameness | 12-month | New hip lameness is defined as new hip claudication in the lateral body treated with an iliac artery branch stent. |
| Aneurysmal enlargement | 12-month | Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery. |
| Secondary patency | 12-month | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. |
| Secondary endovascular repair surgery | 12-month | Secondary endovascular repair is defined as secondary surgical intervention that occurrs during follow-up due to adverse events such as internal leakage and distal limb ischemia. |
| Internal leakage | 12-month | Internal leakage is defined as any type of internal leakage that occurs during the follow-up period. |
Countries
China
Contacts
Primary ContactGuanhua Xue, M.D.
Outcome results
None listed