Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

LifeTech Scientific

Status: Unknown

Conditions: Aortoiliac Aneurysm; Iliac Aneurysm

Treatments: Device: Iliac Bifurcation Stent Graft System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03686189

50CT（CN）

Details and patient eligibility

About

A prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of Iliac Bifurcation Stent Graft System.

Full description

A prospective, multi-center, Single-Arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using Iliac Bifurcation Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. According to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by Iliac Bifurcation Stent Graft System under the guidance of aortic aortography. The safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. The safety and efficacy of aortic endovascular treatment of Iliac Bifurcation Stent Graft System will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Older than 18 years of age.

2. The subject or its legal representative sign the informed consent.

3. Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.

4. The anatomical structure of the iliac artery meets the following requirements:

   1. The length of the anchoring zone of the external iliac artery is ≥15mm.
   2. The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
   3. The diameter of the external iliac artery is between 6mm-10mm.
   4. The length of the anchoring zone of the internal iliac artery is ≥10mm.

5. Life expectancy is longer than one year.

Exclusion criteria

1. The patient is under 18 years old.
2. Pregnant or lactating woman.
3. The patient had a myocardial infarction or stroke within 3 months.
4. The patient had connective tissue disease, infectious aneurysm, and other active infections.
5. The patient has abdominal aortic aneurysm rupture.
6. The patient has a severe coagulation disorder.
7. Allergic to the material of stent or contrast media.
8. Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.
9. Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Intervention arm

Experimental group

Description:

Participants will be treated with Iliac Bifurcation Stent Graft System

Treatment:

Device: Iliac Bifurcation Stent Graft System