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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04016545
Other study ID # 30027/19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date August 1, 2021

Study information

Verified date February 2020
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Giovanni Tinelli
Phone 0039 0630157205
Email giovanni.tinelli@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 1, 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with indications for elective TEVAR

Exclusion Criteria:

- Incapability to provide consent

- Patients not eligible for TEVAR

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Post-operative mortality (intra-operatory and up to 30 days post-surgery) 30 days
Secondary Complications Complications during follow-up 24 months
See also
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