Trials / Not Yet Recruiting
Not Yet RecruitingNCT06162273
An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
Comparing the Efficacy and Safety of IBD Stent of Shenzhen Xianjian Company and IBE Stent of American Gore Company for Reconstruction of Internal Iliac Artery in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2023-12-08
- Last updated
- 2023-12-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06162273. Inclusion in this directory is not an endorsement.