The Study on the Safety and Efficacy of the G-iliac Iliac Bifurcation Stent Graft System
Status
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Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
500 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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