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Aorfix Intelliflex First in Human Study

NCT02907762 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2021-11-01

No results posted yet for this study

Summary

The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with IntelliFlex™, the latest generation of the Aorfix™ AAA Flexible Stent Graft Delivery System, for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0° and 90°.

Conditions

  • Aortic Aneurysm, Abdominal

Interventions

DEVICE

Endovascular aneurysm repair EVAR

Sponsors & Collaborators

  • Lombard Medical

    lead INDUSTRY

Principal Investigators

  • Andrew Holden, MD · University of Auckland, NZ

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-11-30
Completion
2021-11-30

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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 NCT02907762 on ClinicalTrials.gov