Not Yet RecruitingNot Applicable

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

China40 participantsStarted 2023-12-01

Plain-language 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

Who can participate

Age range18 Years – 85 Years

SexALL

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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

What they're measuring

Primary patency

Timeframe: 12-month

Trial details

NCT IDNCT06162273

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-01

Contact for this trial

Guanhua Xue, M.D.

13585785270 guanhuaxue@yeah.net

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials