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European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms

NCT02477111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-04-09

Study results available
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Summary

INSIGHT is a postmarket clinical follow-up study in the European Union. 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 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.

Conditions

  • Abdominal Aortic Aneurysms

Interventions

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

  • Giovanni Torsello, MD, PhD · Universitätsklinikum Münster

  • Jean-Pierre Becquemin, MD, PhD · CHU Henri Mondor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-30
Primary Completion
2016-10-24
Completion
2021-12-09

Countries

  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

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 NCT02477111 on ClinicalTrials.gov