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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Iliac Aneurysm; Aortic Aneurysm, Abdominal

Treatments: Device: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company

Study type: Observational

Funder types: Other

Identifiers

NCT06162273

The SIRI study

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company

Description:

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.

Treatment:

Device: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company