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Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

Primary Purpose

Aortoiliac Aneurysm, Iliac Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Iliac Bifurcation Stent Graft System
Sponsored by
Lifetech Scientific (Shenzhen) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortoiliac Aneurysm focused on measuring Iliac Bifurcation Stent Graft System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical university
  • Chinese PLA General Hospital
  • Peking Union Medical College Hospital
  • The Second Xiangya Hospital of Central South University
  • Zhongshan Hospital Fudan University
  • Tianjin Medical University General Hospital
  • The Frist Affiliated Hospital, Zhejiang University
  • Jiangsu Province Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention arm

Arm Description

Participants will be treated with Iliac Bifurcation Stent Graft System

Outcomes

Primary Outcome Measures

Patency rate of internal iliac artery
Patency rate of internal iliac artery >＝89%

Secondary Outcome Measures

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.
Clinical success rate
The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.
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.
Device related mortality
Deaths related to the device.
Secondary interventional surgery
The rate of secondary interventional surgery for complications related to the device

Full Information

First Posted
September 25, 2018
Last Updated
September 27, 2018
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03686189
Brief Title
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System
Official Title
Safety and Efficacy Study of Iliac Bifurcation Stent Graft System, A Prospective, Multi-centre, Single-Arm Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2, 2015 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortoiliac Aneurysm, Iliac Aneurysm
Keywords
Iliac Bifurcation Stent Graft System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participants will be treated with Iliac Bifurcation Stent Graft System
Intervention Type
Device
Intervention Name(s)
Iliac Bifurcation Stent Graft System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patency rate of internal iliac artery
Description
Patency rate of internal iliac artery >＝89%
Time Frame
180days postoperative
Secondary Outcome Measure Information:
Title
Technical success rate
Description
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.
Time Frame
immediate
Title
Clinical success rate
Description
The diameter of the common iliac artery aneurysm was not expanded or expanded less than 3mm.
Time Frame
30 days and 180days postoperative.
Title
The incidence of major Adverse Device Effects (ADEs)
Description
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.
Time Frame
Before discharge, 30 days and 180 days postoperative。
Title
Device related mortality
Description
Deaths related to the device.
Time Frame
Before discharge, 30 days and 180days postoperative.
Title
Secondary interventional surgery
Description
The rate of secondary interventional surgery for complications related to the device
Time Frame
Before discharge, 30 days and 180days postoperative.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Guo
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical university
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The Frist Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Jiangsu Province Hospital
City
Nankín
Country
China

12. IPD Sharing Statement

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Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

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