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NCT Number: NCT06660927

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Common Iliac Artery Aneurysm

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese PLA General Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liac Bifurcation Stent Graft System

Device

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

Primary outcomes

  1. The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.

    Time frame: 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.

  2. he patency rate of internal iliac artery (IIA) at 12 months postoperatively

    Time frame: at 12 months postoperatively

    The patency rate of internal iliac artery (IIA) defined as blood flow without occlusion maintained through the device without intervention

Secondary outcomes

  1. The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.

    Time frame: 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.

  2. Device-related adverse events before discharge and at 12 months postoperatively

    Time frame: 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.

  3. The incidence of malfunction before discharge and at 12 months postoperatively.

    Time frame: 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.

  4. Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.

    Time frame: 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.

  5. The immediate technical success during intraoperative procedures.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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