Clinical trial NCT06660927: The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Common Iliac Artery Aneurysm
Keywords: Lifetech
Iliac Bifurcation Stent Graft System
Endovascular Repair
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Major Adverse Events (MAE) within 30 Days postoperatively.
timeFrame: within 30 Days postoperatively
measure: he patency rate of internal iliac artery (IIA) at 12 months postoperatively
timeFrame: at 12 months postoperatively
Secondary outcomes:
measure: The incidence of conversion to open surgery or secondary interventional procedures due to iliac artery aneurysms before discharge and at 12 months postoperatively.
timeFrame: before discharge and at 12 months postoperatively
measure: Device-related adverse events before discharge and at 12 months postoperatively
timeFrame: before discharge and at 12 months postoperatively.
measure: The incidence of malfunction before discharge and at 12 months postoperatively.
timeFrame: before discharge and at 12 months postoperatively.
measure: Incidence rate of Type I/III endoleak caused by the iliac bifurcation system that necessitate reintervention before discharge and at 12 months postoperatively.
timeFrame: before discharge and at 12 months postoperatively.
measure: The immediate technical success during intraoperative procedures.
timeFrame: during intraoperative procedures
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: hongpeng zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: