Safety and Efficacy Study of Iliac Bifurcation Stent Graft System

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

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

Study Overview

• Status: Unknown
• Conditions: Iliac Aneurysm; Aortoiliac Aneurysm
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention arm; Participants will be treated with Iliac Bifurcation Stent Graft System

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.

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.

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Wei Guo, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2015
• Primary Completion (Anticipated): November 30, 2018
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Iliac Bifurcation Stent Graft System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: 50CT（CN）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No