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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Aneurysm, Abdominal; Iliac Aneurysm
• Intervention / Treatment: Device: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Guanhua Xue, M.D.; Phone Number: 13585785270; Email: guanhuaxue@yeah.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	CTA showed patency of the preserved internal iliac artery.	12-month

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Internal iliac artery; Iliac artery branch stent; Patency rate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Iliac Aneurysm
• Other Study ID Numbers: The SIRI study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No