Status:
NOT_YET_RECRUITING
An Exploratory Study of Iliac Artery Branch Stent for Internal Iliac Artery Reconstruction in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
Lead Sponsor:
RenJi Hospital
Conditions:
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Eligibility:
All Genders
18-85 years
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 an...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06162273
Start Date
December 1 2023
End Date
December 1 2026
Last Update
December 8 2023
Active Locations (1)
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1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127