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Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System

NCT03687489 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2019-12-30

No results posted yet for this study

Summary

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the infrarenal abdominal aortic aneurysm.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

Abdominal Aortic Aneurysm Stent Graft System

Abdominal aortic bifurcation stent and iliac artery extension stent were preloaded into abdominal aortic bifurcation stent transporter and iliac artery extension stent transporter, respectively. In the operation, the abdominal aorta bifurcation stent and the iliac artery extension stent will be delivered to the corresponding lesion position of the abdominal iliac artery and release. The abdominal aortic bifurcation stent and the iliac artery extension stent will form a whole through docking and thereby reducing the risk of rupture of an infrarenal abdominal aortic aneurysm due to the shock of blood flow.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Guo, Professor · Chinese PLA General Hospita

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-11-30
Completion
2025-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687489 on ClinicalTrials.gov