Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

Not Applicable

• Conditions: Iliac Aneurysm; Aortoiliac Aneurysm
• Interventions: Device: Iliac Bifurcation Stent Graft System

• Registration Number: NCT03686189
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Study Start: 2015-07-02
• Status Verified: 2018-09
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-09-28
• Primary Completion: 2018-11-30
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Iliac Bifurcation Stent Graft System	Participants will be treated with Iliac Bifurcation Stent Graft System

Primary Outcome Measures

Name	Time	Method
Patency rate of internal iliac artery	180days postoperative	Patency rate of internal iliac artery \>＝89%

Secondary Outcome Measures

Name	Time	Method
Clinical success rate	30 days and 180days postoperative.	The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.
Device related mortality	Before discharge, 30 days and 180days postoperative.	Deaths related to the device.
Secondary interventional surgery	Before discharge, 30 days and 180days postoperative.	The rate of secondary interventional surgery for complications related to the device
The incidence of major Adverse Device Effects (ADEs)	Before discharge, 30 days and 180 days postoperative。	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.
Technical success rate	immediate	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.

Trial Locations

Locations (8)

Beijing Anzhen Hospital, Capital Medical university; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The Frist Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Jiangsu Province Hospital; 🇨🇳 Nankín, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China