Abdominal Aortic AneurysmCO2-EVARNCT04721951
An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair
An observational study of Abdominal Aortic Aneurysm, run by University of Bologna at 1 site in Italy.
Trial summary
The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Endovascular Aortic Repair using Carbon Dioxide Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2018to 26 Jan 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with AAA, undergoing EVAR
Who may be able to join
- Age > 18 years
- Male, female
- Patients with indication for AAA
- Informed consent achievement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of experimental diagnostic and specialty medicine - Vascular Surgery
Bologna, 40138
About this study
Official title: CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)
The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Endovascular Aortic Repair using Carbon Dioxide Angiography
- Keywords
- Endovascular Aortic Repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Aortic Repair using Carbon Dioxide AngiographyProcedure or surgery
Endovascular Aortic Repair using Carbon Dioxide Angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 Days
Secondary outcomes (5)
Image Quality
Image quality for guiding the procedure defined as good for stent-graft implantation or low not allowing stent-graft implantation
Measured: 30 Days
Endoleak Detection
Type I-IV endoleak detection
Measured: 30 Days
CO2 Quantity
Amount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)
Measured: 30 Days
Aneurysm Exclusion
Aneurysm exclusion without type I or III endoleaks at the CT scan at discharge
Measured: 30 Days
Adverse Events
Any adverse event within 24 hours
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start12 Dec 2018
- Primary completion31 Dec 2021
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Vacirca, University of Bologna
- Investigators
- Mauro Gargiulo, Prof, Principal investigator, Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721951
- Sponsor's protocol ID
- CO2-EVAR
- Acronym
- CO2-EVAR
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)
- ClinicalTrials.gov ID
- NCT04721951
- Acronym / sponsor ID
- CO2-EVAR / CO2-EVAR
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Endovascular Aortic Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with AAA, undergoing EVAR
Key inclusion criteria (4 listed)
- Age > 18 years
- Male, female
- Patients with indication for AAA
- Informed consent achievement
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Aortic Repair using Carbon Dioxide AngiographyEndovascular Aortic Repair using Carbon Dioxide Angiography | Procedure or surgery | – |
Primary outcome
Technical Success
Time frame: 30 Days
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)
5 secondary outcomes
Image Quality
Time frame: 30 Days
Endoleak Detection
Time frame: 30 Days
CO2 Quantity
Time frame: 30 Days
Aneurysm Exclusion
Time frame: 30 Days
Adverse Events
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Gargiulo, Prof principal investigator
Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.