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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency | CTA showed patency of the preserved internal iliac artery. | 12-month |
| Measure | Description | Time Frame |
|---|---|---|
| New hip lameness | New hip lameness is defined as new hip claudication in the lateral body treated with an iliac artery branch stent. | 12-month |
| Internal leakage | Internal leakage is defined as any type of internal leakage that occurs during the follow-up period. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guanhua Xue, M.D. | Contact | 13585785270 | guanhuaxue@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
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| 12-month |
| Aneurysmal enlargement | Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery. | 12-month |
| Aneurysm rupture | Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up. | 12-month |
| Secondary patency | Secondary patency is defined as maintaining patency in the target vessel after a repeat intervention to correct complete occlusion in the treated arterial segment. | 12-month |
| Secondary endovascular repair surgery | 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. | 12-month |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D017543 | Iliac Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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