Recruiting NCT04016545
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
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 →
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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