An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06162273
• Other study ID #: The SIRI study
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: December 2023
• Source: RenJi Hospital
• Contact: Guanhua Xue, M.D.
• Phone: 13585785270
• Email: guanhuaxue[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Iliac Aneurysm

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency	CTA showed patency of the preserved internal iliac artery.	12-month
Secondary	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
Secondary	Internal leakage	Internal leakage is defined as any type of internal leakage that occurs during the follow-up period.	12-month
Secondary	Aneurysmal enlargement	Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery.	12-month
Secondary	Aneurysm rupture	Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up.	12-month
Secondary	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	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