MedTrace Logo

ZEnith AlPHa for AneurYsm Repair

NCT03165279 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 354

Last updated 2022-07-20

No results posted yet for this study

Summary

To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

Conditions

  • Aneurysm

Interventions

PROCEDURE

Zenith Alpha Abdominal stentgraft

Sponsors & Collaborators

  • Syntactx

    collaborator NETWORK

  • Philippe Cuypers

    lead OTHER

Principal Investigators

  • Philippe Cuypers, MD, PhD · Catharina Ziekenhuis Eindhoven

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-07
Primary Completion
2022-05-31
Completion
2022-07-31

Countries

  • Belgium
  • Germany
  • Netherlands

Study Locations

More Related Trials

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 NCT03165279 on ClinicalTrials.gov