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

NCT06162273 | Not Yet Recruiting DMC

• 1 other identifier: The SIRI study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aortic Aneurysm, Abdominal; Iliac Aneurysm

Keywords

Iliac artery branch stent; Patency rate; Internal iliac artery

Outcome Measures

Primary Outcomes (1)

• Primary patency

  CTA showed patency of the preserved internal iliac artery.

  12-month

Secondary Outcomes (6)

• New hip lameness

  12-month

• Internal leakage

  12-month

• Aneurysmal enlargement

  12-month

• Aneurysm rupture

  12-month

• Secondary patency

  12-month

Study Arms (1)

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
• Male or female ≥18 years old, ≤85 years old;
• Life expectancy \> 2 years;
• 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.

You may not qualify if:

• Fungal or ruptured aneurysm
• Known complications of thoracic aortic aneurysm require interventional treatment
• American Association of Anesthesiologists (ASA) Grade V
• Creatinine \> 2.5mg/dL or dialysis patients
• NYHA Grade IV heart failure
• Intercalation, severe calcification, or anchoring area with thrombosis
• Severe curvature or narrowing of the iliac and/or femoral arteries, resulting in difficulty in stent delivery
• Conduct another device or drug study within 1 year of treatment
• Systemic infection
• Combined with connective tissue disease
• Known history of drug use
• Known allergies or allergies to equipment materials

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Iliac Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Guanhua Xue, M.D.

CONTACT

13585785270; guanhuaxue@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

CN (1)