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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04016545

Enrollment

200

Registered

2019-07-11

Start date

2019-10-01

Completion date

2027-08-01

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-operative Mortality

Brief summary

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

Interventions

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

Aortic aneurysm exclusion through endovascular procedure

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with indications for elective TEVAR

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	30 days	Post-operative mortality (intra-operatory and up to 30 days post-surgery)

Secondary

Measure	Time frame	Description
Complications	24 months	Complications during follow-up

Countries

Italy

Contacts

Primary ContactGiovanni Tinelli

giovanni.tinelli@policlinicogemelli.it0039 0630157205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026