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Global Post-market Registry for the Treovance Stent-graft.

NCT03449875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 202

Last updated 2020-06-26

No results posted yet for this study

Summary

Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

TREOVANCE® Stent-Graft with Navitel® Delivery System

Endovascular repair of abdominal aortic aneurysms.

Sponsors & Collaborators

  • Bolton Medical

    lead INDUSTRY

Principal Investigators

  • Carlo Setacci, MD, PhD · Department of Medicine, Surgery and Neuroscience, University of Siena Viale Bracci 1, 53100 Siena, Italy

Eligibility

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

Timeline & Regulatory

Start
2014-02-05
Primary Completion
2017-04-11
Completion
2017-04-11

Countries

  • Chile
  • Denmark
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Thailand
  • United Kingdom
  • Venezuela
  • Vietnam

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 NCT03449875 on ClinicalTrials.gov