Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

Iliac Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03686189
• Other study ID #: 50CT(CN)
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2, 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2018
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: January 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortoiliac Aneurysm
• Iliac Aneurysm

Intervention

Device:
• Iliac Bifurcation Stent Graft System
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.

Locations

Country	Name	City	State
China	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	Jiangsu Province Hospital	Nankín
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate of internal iliac artery	Patency rate of internal iliac artery >=89%	180days postoperative
Secondary	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
Secondary	Clinical success rate	The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.	30 days and 180days postoperative.
Secondary	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?
Secondary	Device related mortality	Deaths related to the device.	Before discharge, 30 days and 180days postoperative.
Secondary	Secondary interventional surgery	The rate of secondary interventional surgery for complications related to the device	Before discharge, 30 days and 180days postoperative.