Clinical trial NCT06162273: An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Aneurysm, Abdominal
Iliac Aneurysm
Keywords: Iliac artery branch stent
Patency rate
Internal iliac artery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with iliac aneurysms/abdominal aortic aneurysms requiring iliac branch stents

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary patency
timeFrame: 12-month
Secondary outcomes:
measure: New hip lameness
timeFrame: 12-month
measure: Internal leakage
timeFrame: 12-month
measure: Aneurysmal enlargement
timeFrame: 12-month
measure: Aneurysm rupture
timeFrame: 12-month
measure: Secondary patency
timeFrame: 12-month
measure: Secondary endovascular repair surgery
timeFrame: 12-month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
References: