An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company.
- Who it may be relevant to
- Registry conditions: Aortic Aneurysm, Abdominal, Iliac Aneurysm. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Primary patency [Time frame: 12-month]
Secondary outcome measures (6)
- New hip lameness [Time frame: 12-month]
- Internal leakage [Time frame: 12-month]
- Aneurysmal enlargement [Time frame: 12-month]
- Aneurysm rupture [Time frame: 12-month]
- Secondary patency [Time frame: 12-month]
- Secondary endovascular repair surgery [Time frame: 12-month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Renji Hospital — Shanghai
Identifiers
NCT: NCT06162273 · The SIRI study