The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System

A Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms

The objective of this study is to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA).

Study Overview

• Status: Active, not recruiting
• Conditions: Common Iliac Artery Aneurysm
• Intervention / Treatment: Device: liac Bifurcation Stent Graft System

Detailed Description

The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have undergone implantation of the iliac bifurcation stent graft system;
• Patients with complete medical records

Exclusion Criteria:

• Patients with ruptured aortic aneurysm;
• Patients with infected or mycotic aortic aneurysm;
• Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Endovascular Treatment of Patients with Common Iliac Artery Aneurysms; Endovascular Treatment of Patients with Common Iliac Artery Aneurysms Using the Iliac Bifurcation Stent Graft System	Device: liac Bifurcation Stent Graft System; to evaluate the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System for Endovascular Repair of Common Iliac Artery Aneurysms(CIAA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.	Major Adverse Events (MAE) are defined as follows: all-cause mortality related to iliac artery aneurysms associated with the surgery or device, myocardial infarction, renal failure, respiratory failure, paraplegia, stroke, and intestinal ischemia.	within 30 Days postoperatively
he patency rate of internal iliac artery (IIA) at 12 months postoperatively	The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention	at 12 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.	Notes: Due to the patient's condition, the surgeon's choice of staged reconstruction does not constitute a secondary surgical intervention.	before discharge and at 12 months postoperatively
Device-related adverse events before discharge and at 12 months postoperatively	Device-related adverse events are those situations that are ultimately determined to be definitely related, possibly related, or indeterminate with respect to the study device.	before discharge and at 12 months postoperatively.
The incidence of malfunction before discharge and at 12 months postoperatively.	Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended.Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.	before discharge and at 12 months postoperatively.
Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.	Type I endoleak, also known as peri-graft endoleak or graft-related endoleak, refers to the leakage caused by the inability of the stent graft to tightly adhere to the autologous vessel, leading to continuous blood flow into the aneurysm sac. This includes proximal and distal Type I endoleaks. Type III endoleak refers to the leakage caused by the inability of the stent graft's own connectors to tightly adhere or the rupture of the artificial vessel, which results in continuous blood flow into the aneurysm sac.	before discharge and at 12 months postoperatively.
The immediate technical success during intraoperative procedures.	immediate technical success refers to successful delivery of the stent to the intended location by the delivery system, successful deployment of the stent, and safe removal of the delivery system. Additionally, angiography should show unobstructed blood flow within the stent, with no stent kinking, folding, narrowing, or occlusion.	during intraoperative procedures

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: hongpeng zhang, Professor, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Endovascular Repair; Iliac Bifurcation Stent Graft System; Lifetech
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Iliac Aneurysm
• Other Study ID Numbers: 50CT(CN) L-01

Drug and device information, study documents

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