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

Recruiting

• Conditions: Peri-operative Mortality
• Interventions: Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)

• Registration Number: NCT04016545
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Study Start: 2019-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with indications for elective TEVAR

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated patients	Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)	-

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	Post-operative mortality (intra-operatory and up to 30 days post-surgery)

Secondary Outcome Measures

Name	Time	Method
Complications	24 months	Complications during follow-up

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, RM, Italy