NCT04721951

Brief Summary

The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 12, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

January 19, 2021

Last Update Submit

January 27, 2022

Conditions

Abdominal Aortic Aneurysm

Keywords

Endovascular Aortic Repair

Outcome Measures

Primary Outcomes (1)

  • Technical Success

    Technical success to assess the renal ostia and the hypogastric arteries (defined as 100% accuracy correlated to the iodinated contrast agent angiography or IVUS/FUSION techniques)

    30 Days

Secondary Outcomes (5)

  • Image Quality

    30 Days

  • Endoleak Detection

    30 Days

  • CO2 Quantity

    30 Days

  • Aneurysm Exclusion

    30 Days

  • Adverse Events

    30 Days

Interventions

Endovascular Aortic Repair using Carbon Dioxide AngiographyPROCEDURE

Endovascular Aortic Repair using Carbon Dioxide Angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with AAA, undergoing EVAR

You may qualify if:

  • Age \> 18 years
  • Male, female
  • Patients with indication for AAA
  • Informed consent achievement

You may not qualify if:

  • Severe COPD (Chronic Obstructive Pulmonary Disease)
  • Known atrium- or ventricular septal defect with right-left-shunt
  • Severe renal arteries atherosclerosis
  • Ruptured AAA
  • Current partecipation in other interventional studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of experimental diagnostic and specialty medicine - Vascular Surgery

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Mauro Gargiulo, Prof

    Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 25, 2021

Study Start

December 12, 2018

Primary Completion

December 31, 2021

Study Completion

January 26, 2022

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

IT(1)