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China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)

NCT03965364 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2021-02-26

No results posted yet for this study

Summary

INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 120 subjects will be enrolled and followed through 1-years postprocedure. Up to 20 sites in China may participate.

Conditions

  • Abdominal Aortic Aneurysms

Interventions

DEVICE

INCRAFT

Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Zhong Chen, Doctor · Beijing Anzhen Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2020-08-31
Completion
2021-12-31
FDA Device
Yes

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 NCT03965364 on ClinicalTrials.gov