Recruiting

NCT Number: NCT04016545

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

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

Recruiting

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Key information

Conditions

Peri-operative Mortality

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

Location status: Recruiting

Location contact

Giovanni Tinelli

CONTACT

[email protected]

0039 0630157205

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with indications for elective TEVAR

Exclusion criteria

Incapability to provide consent
Patients not eligible for TEVAR
Pregnancy

Treatment and study plan

Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)

Device

Aortic aneurysm exclusion through endovascular procedure

Primary outcomes

Mortality

Time frame: 30 days

Post-operative mortality (intra-operatory and up to 30 days post-surgery)

Secondary outcomes

Complications

Time frame: 24 months

Complications during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Tinelli

CONTACT

[email protected]

0039 0630157205

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2027
First posted: Jul 11, 2019
Registry last updated: Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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