Safety and Efficacy Study of Iliac Bifurcation Stent Graft System
NCT ID: NCT03686189
Last Updated: 2018-09-28
Study Results
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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UNKNOWN
NA
64 participants
INTERVENTIONAL
2015-07-02
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention arm
Participants will be treated with Iliac Bifurcation Stent Graft System
Iliac Bifurcation Stent Graft System
Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.
Interventions
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Iliac Bifurcation Stent Graft System
Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.
Eligibility Criteria
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Inclusion Criteria
2. The subject or its legal representative sign the informed consent.
3. Patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery.
4. The anatomical structure of the iliac artery meets the following requirements:
1. The length of the anchoring zone of the external iliac artery is ≥15mm.
2. The diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm.
3. The diameter of the external iliac artery is between 6mm-10mm.
4. The length of the anchoring zone of the internal iliac artery is ≥10mm.
5. Life expectancy is longer than one year.
Exclusion Criteria
2. Pregnant or lactating woman.
3. The patient had a myocardial infarction or stroke within 3 months.
4. The patient had connective tissue disease, infectious aneurysm, and other active infections.
5. The patient has abdominal aortic aneurysm rupture.
6. The patient has a severe coagulation disorder.
7. Allergic to the material of stent or contrast media.
8. Patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery.
9. Patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of Branch Stent.
18 Years
ALL
No
Sponsors
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Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Guo
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Beijing Anzhen Hospital, Capital Medical university
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Frist Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Jiangsu Province Hospital
Nanjing, , China
Countries
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Other Identifiers
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50CT（CN）
Identifier Type: -
Identifier Source: org_study_id