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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorRenJi Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company1 intervention

Trial outcomes

Primary outcomes

1

Primary patency

CTA showed patency of the preserved internal iliac artery.

Time frame
12-month

Secondary outcomes

1

New hip lameness

New hip lameness is defined as new hip claudication in the lateral body treated with an iliac artery branch stent.

Time frame
12-month
2

Internal leakage

Internal leakage is defined as any type of internal leakage that occurs during the follow-up period.

Time frame
12-month
3

Aneurysmal enlargement

Aneurysm enlargement is defined as having a larger aneurysm diameter during follow-up than before surgery.

Time frame
12-month
4

Aneurysm rupture

Ruptured aneurysms is defined as ruptured abdominal aortic aneurysms or iliac aneurysms that occurrs during follow-up.

Time frame
12-month

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: