Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

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

Detailed 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.

Official Title
-----------------
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial

Conditions
-----------------
Aortoiliac Aneurysm, Iliac Aneurysm

Intervention / Treatment
-----------------
* Device: Iliac Bifurcation Stent Graft System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years of age. The subject or its legal representative sign the informed consent. Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery. The anatomical structure of the iliac artery meets the following requirements: The length of the anchoring zone of the external iliac artery is ≥15mm. The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm. The diameter of the external iliac artery is between 6mm-10mm. The length of the anchoring zone of the internal iliac artery is ≥10mm. Life expectancy is longer than one year. Exclusion Criteria: The patient is under 18 years old. Pregnant or lactating woman. The patient had a myocardial infarction or stroke within 3 months. The patient had connective tissue disease, infectious aneurysm, and other active infections. The patient has abdominal aortic aneurysm rupture. The patient has a severe coagulation disorder. Allergic to the material of stent or contrast media. Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery. Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants will be treated with Iliac Bifurcation Stent Graft System | Device: Iliac Bifurcation Stent Graft System<br>* Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate of internal iliac artery | Patency rate of internal iliac artery >＝89% | 180days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | After implantation of the stent and observed under common iliac artery angiography, the stent was in the right position and adhered well to the vessel wall, with no leakage. | immediate | 
| Clinical success rate | The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm. | 30 days and 180days postoperative. | 
| The incidence of major Adverse Device Effects (ADEs) | Major Adverse Device Effects including death, myocardial infarction, arterial thrombosis, renal function failure, respiratory failure, paraplegia, stroke, gluteus claudication, colon, spinal cord ischemia necrosis, perineum, iliac artery blockages, external iliac vein blockage, expand common iliac artery aneurysms (increased diameter 3 mm), common iliac artery aneurysms rupture, internal leakage (type I and type III), stent fracture, stent displacement. | Before discharge, 30 days and 180 days postoperative。 | 
| Device related mortality | Deaths related to the device. | Before discharge, 30 days and 180days postoperative. | 
| Secondary interventional surgery | The rate of secondary interventional surgery for complications related to the device | Before discharge, 30 days and 180days postoperative. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iliac Bifurcation Stent Graft System