NCT04016545

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2019Aug 2027

First Submitted

Initial submission to the registry

July 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

6.8 years

First QC Date

July 9, 2019

Last Update Submit

March 15, 2025

Conditions

Peri-operative Mortality

Outcome Measures

Primary Outcomes (1)

  • Mortality

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

    30 days

Secondary Outcomes (1)

  • Complications

    24 months

Study Arms (1)

Treated patients

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

Interventions

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

Aortic aneurysm exclusion through endovascular procedure

Treated patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for elective TEVAR treatable with low-profile endoprothesis

You may qualify if:

  • Patients with indications for elective TEVAR

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

Central Study Contacts

Giovanni Tinelli

CONTACT

0039 0630157205giovanni.tinelli@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Vascular Surgery

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 11, 2019

Study Start

October 1, 2019

Primary Completion

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

IT(1)