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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Common Iliac Artery Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

liac Bifurcation Stent Graft System

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No