Menu
Recruiting NCT04016545

Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

Observational Peri-operative Mortality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo).
Who it may be relevant to
Registry conditions: Peri-operative Mortality. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.

Interventions

  • Device Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
    Aortic aneurysm exclusion through endovascular procedure

Primary outcome measures

  • Mortality [Time frame: 30 days]
Secondary outcome measures (1)
  • Complications [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Patients with indications for elective TEVAR

Exclusion criteria

  • Incapability to provide consent
  • Patients not eligible for TEVAR
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Identifiers

NCT: NCT04016545 · 30027/19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗