Thoracoabdominal Aortic AneurysmNCT06103942
Automated Carbon Dioxide Angiography in Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair
An observational study of Thoracoabdominal Aortic Aneurysm, run by Uppsala University.
Trial summary
Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- What is being tested?
- CO2 angiography
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 2025
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a formal indication to an endovascular treatment of complex throacoabdominal aneurysms.
Who may be able to join
- Patients with indication for treatment of complex TAAA according to accepted international guidelines
- Provided informed consent
Who cannot join
- Severe COPD (Chronic Obstructive Pulmonary Disease), GOLD Stage 3 and 4
- Known atrium- or ventricular septal defect with right-left-shunt
- Current participation in other interventional studies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Automated Carbon Dioxide Angiography in Comparison to Iodinated Contrast Medium Angiography During Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair (F/B-EVAR)
Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent.
Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.
Read more
Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.
A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.
The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.
Read the detailed description
Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. This practice started in 1970s and it is commonly used for patients who have an impaired renal function, allergy to iodinated contrast media (ICM) or that could have a contrast-induced nephropathy (CIN) risk.
Carbon dioxide is an effective and low-risk alternative to ICM, which is nowadays used in endovascular procedures, thanks to its unique properties, such as no risk for nephrotoxicity or allergic reaction. For many years, the two most important restrictions for this technique consisted of: 1) the absence of a delivery system that could minimize the risk of air contamination during the CO2 angiography and allow controlled injection (in terms of pressure and volume of injection) of the CO2 and 2) the absence of a customized imaging protocol for a better visualization of CO2 during DSA acquisition.
Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.
Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.
A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.
The literature on CO2 angiography still lacks on studies regarding the systematic use of the technique in F/B-EVAR procedures.
The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.
The main study hypothesis is that the automated standardized injection of CO2 could provide the same angiographic information and image quality as ICM, which is nowadays used as standard contrast agent in endovascular procedures.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Being tested
- CO2 angiography
- Keywords
- FEVAR, BEVAR, CO2, complex aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 angiographyDiagnostic test
A supplemental CO2 angiography will be performed before and after the stent graft placement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Technical success in terms of detecting the ostium of the visceral vessels as well as of the hypogastric arteries (defined as 100% accuracy when compared to the iodinated contrast agent angiography)
Measured: at the time the intervention
CO2 sensitivity and specificity compared to iodinated contrast agent angiography
CO2 sensitivity and specificity compared to iodinated contrast agent angiography in detecting dissections, stenosis, occlusions or bleeding of the target vessel. The comparison will be blinded and retrospective.
Measured: at the time the intervention
Secondary outcomes (1)
Image quality
Image quality with regard to the CO2 angiography defined as poor, moderate and good. The analysis of the images will be retrospective.
Measured: at the time the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Asciutto, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103942
- Sponsor's protocol ID
- Nov2023
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rolland Y, Duvauferrier R, Lucas A, Gourlay C, Morcet N, Rambeau M, Chaperon J. Lower limb angiography: a prospective study comparing carbon dioxide with iodinated contrast material in 30 patients. AJR Am J Roentgenol. 1998 Aug;171(2):333-7. doi: 10.2214/ajr.171.2.9694446.
PubMed 9694446Palena LM, Diaz-Sandoval LJ, Candeo A, Brigato C, Sultato E, Manzi M. Automated Carbon Dioxide Angiography for the Evaluation and Endovascular Treatment of Diabetic Patients With Critical Limb Ischemia. J Endovasc Ther. 2016 Feb;23(1):40-8. doi: 10.1177/1526602815616924. Epub 2015 Nov 13.
PubMed 26567126Scalise F, Novelli E, Auguadro C, Casali V, Manfredi M, Zannoli R. Automated carbon dioxide digital angiography for lower-limb arterial disease evaluation: safety assessment and comparison with standard iodinated contrast media angiography. J Invasive Cardiol. 2015 Jan;27(1):20-6.
PubMed 25589696Seeger JM, Self S, Harward TR, Flynn TC, Hawkins IF Jr. Carbon dioxide gas as an arterial contrast agent. Ann Surg. 1993 Jun;217(6):688-97; discussion 697-8. doi: 10.1097/00000658-199306000-00011.
PubMed 8507115Caridi JG, Hawkins IF Jr. CO2 digital subtraction angiography: potential complications and their prevention. J Vasc Interv Radiol. 1997 May-Jun;8(3):383-91. doi: 10.1016/s1051-0443(97)70577-3. No abstract available.
PubMed 9152911Bettmann MA, D'Agostino R, Juravsky LI, Jeffery RF, Tottle A, Goudey CP. Carbon dioxide as an angiographic contrast agent. A prospective randomized trial. Invest Radiol. 1994 Jun;29 Suppl 2:S45-6. doi: 10.1097/00004424-199406001-00016. No abstract available.
PubMed 7928269Hawkins IF Jr, Wilcox CS, Kerns SR, Sabatelli FW. CO2 digital angiography: a safer contrast agent for renal vascular imaging? Am J Kidney Dis. 1994 Oct;24(4):685-94. doi: 10.1016/s0272-6386(12)80232-0.
PubMed 7942829D'Oria M, Wanhainen A, Lindstrom D, Tegler G, Mani K. Editor's Choice - Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair. Eur J Vasc Endovasc Surg. 2021 Dec;62(6):859-868. doi: 10.1016/j.ejvs.2021.08.033. Epub 2021 Oct 27.
PubMed 34716095Gallitto E, Faggioli G, Vacirca A, Pini R, Mascoli C, Fenelli C, Logiacco A, Abualhin M, Gargiulo M. The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting. J Vasc Surg. 2020 Dec;72(6):1906-1916. doi: 10.1016/j.jvs.2020.02.051. Epub 2020 Apr 8.
PubMed 32276017Chisci E, Michelagnoli S, Masciello F, Turini F, Panci S, Troisi N. Benefits and Role of Carbon Dioxide Angiography in Case of Misalignment Between Fenestration and Target Vessel During Fenestrated Endovascular Aneurysm Repair. J Endovasc Ther. 2022 Feb;29(1):7-10. doi: 10.1177/15266028211032955. Epub 2021 Aug 8.
PubMed 34369173Geisbusch S, Kuehnl A, Salvermoser M, Reutersberg B, Trenner M, Eckstein HH. Editor's Choice - Hospital Incidence, Treatment, and In Hospital Mortality Following Open and Endovascular Surgery for Thoraco-abdominal Aortic Aneurysms in Germany from 2005 to 2014: Secondary Data Analysis of the Nationwide German DRG Microdata. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):488-498. doi: 10.1016/j.ejvs.2018.10.030. Epub 2019 Feb 7.
PubMed 30745030de Lachomette MF, Della N, Maucort-Boulch D, Duprey A, Rosset E, Feugier P, Lermusiaux P, Albertini JN, Millon A. Renal Function after Fenestrated or Branched Endovascular Aortic Repair: The Early Impairment Predictive Factors. Ann Vasc Surg. 2017 Apr;40:1-9. doi: 10.1016/j.avsg.2016.06.014. Epub 2016 Aug 27.
PubMed 27575304
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Carbon Dioxide Angiography in Comparison to Iodinated Contrast Medium Angiography During Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair (F/B-EVAR)
- ClinicalTrials.gov ID
- NCT06103942
- Acronym / sponsor ID
- Nov2023
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Keywords
- FEVAR, BEVAR, CO2, complex aortic aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Oct 2023 (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.
Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent.
Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.
Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.
A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.
The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.
Detailed description
Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. This practice started in 1970s and it is commonly used for patients who have an impaired renal function, allergy to iodinated contrast media (ICM) or that could have a contrast-induced nephropathy (CIN) risk.
Carbon dioxide is an effective and low-risk alternative to ICM, which is nowadays used in endovascular procedures, thanks to its unique properties, such as no risk for nephrotoxicity or allergic reaction. For many years, the two most important restrictions for this technique consisted of: 1) the absence of a delivery system that could minimize the risk of air contamination during the CO2 angiography and allow controlled injection (in terms of pressure and volume of injection) of the CO2 and 2) the absence of a customized imaging protocol for a better visualization of CO2 during DSA acquisition.
Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.
Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.
A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.
The literature on CO2 angiography still lacks on studies regarding the systematic use of the technique in F/B-EVAR procedures.
The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.
The main study hypothesis is that the automated standardized injection of CO2 could provide the same angiographic information and image quality as ICM, which is nowadays used as standard contrast agent in endovascular procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a formal indication to an endovascular treatment of complex throacoabdominal aneurysms.
Key inclusion criteria (2 listed)
- Patients with indication for treatment of complex TAAA according to accepted international guidelines
- Provided informed consent
Key exclusion criteria (3 listed)
- Severe COPD (Chronic Obstructive Pulmonary Disease), GOLD Stage 3 and 4
- Known atrium- or ventricular septal defect with right-left-shunt
- Current participation 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 |
|---|---|---|
| CO2 angiographyA supplemental CO2 angiography will be performed before and after the stent graft placement. | Diagnostic test | – |
Primary outcome
Technical success
Time frame: at the time the intervention
Technical success in terms of detecting the ostium of the visceral vessels as well as of the hypogastric arteries (defined as 100% accuracy when compared to the iodinated contrast agent angiography)
CO2 sensitivity and specificity compared to iodinated contrast agent angiography
Time frame: at the time the intervention
CO2 sensitivity and specificity compared to iodinated contrast agent angiography in detecting dissections, stenosis, occlusions or bleeding of the target vessel. The comparison will be blinded and retrospective.
1 secondary outcome
Image quality
Time frame: at the time the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Results publication: PubMed 9694446Rolland Y, Duvauferrier R, Lucas A, Gourlay C, Morcet N, Rambeau M, Chaperon J. Lower limb angiography: a prospective study comparing carbon dioxide with iodinated contrast material in 30 patients. AJR Am J Roentgenol. 1998 Aug;171(2):333-7. doi: 10.2214/ajr.171.2.9694446.
- Results publication: PubMed 26567126Palena LM, Diaz-Sandoval LJ, Candeo A, Brigato C, Sultato E, Manzi M. Automated Carbon Dioxide Angiography for the Evaluation and Endovascular Treatment of Diabetic Patients With Critical Limb Ischemia. J Endovasc Ther. 2016 Feb;23(1):40-8. doi: 10.1177/1526602815616924. Epub 2015 Nov 13.
- Results publication: PubMed 25589696Scalise F, Novelli E, Auguadro C, Casali V, Manfredi M, Zannoli R. Automated carbon dioxide digital angiography for lower-limb arterial disease evaluation: safety assessment and comparison with standard iodinated contrast media angiography. J Invasive Cardiol. 2015 Jan;27(1):20-6.
- Results publication: PubMed 8507115Seeger JM, Self S, Harward TR, Flynn TC, Hawkins IF Jr. Carbon dioxide gas as an arterial contrast agent. Ann Surg. 1993 Jun;217(6):688-97; discussion 697-8. doi: 10.1097/00000658-199306000-00011.
- Results publication: PubMed 9152911Caridi JG, Hawkins IF Jr. CO2 digital subtraction angiography: potential complications and their prevention. J Vasc Interv Radiol. 1997 May-Jun;8(3):383-91. doi: 10.1016/s1051-0443(97)70577-3. No abstract available.
- Results publication: PubMed 7928269Bettmann MA, D'Agostino R, Juravsky LI, Jeffery RF, Tottle A, Goudey CP. Carbon dioxide as an angiographic contrast agent. A prospective randomized trial. Invest Radiol. 1994 Jun;29 Suppl 2:S45-6. doi: 10.1097/00004424-199406001-00016. No abstract available.
- Results publication: PubMed 7942829Hawkins IF Jr, Wilcox CS, Kerns SR, Sabatelli FW. CO2 digital angiography: a safer contrast agent for renal vascular imaging? Am J Kidney Dis. 1994 Oct;24(4):685-94. doi: 10.1016/s0272-6386(12)80232-0.
- Results publication: PubMed 34716095D'Oria M, Wanhainen A, Lindstrom D, Tegler G, Mani K. Editor's Choice - Pre-Operative Moderate to Severe Chronic Kidney Disease is Associated with Worse Short-Term and Mid-Term Outcomes in Patients Undergoing Fenestrated-Branched Endovascular Aortic Repair. Eur J Vasc Endovasc Surg. 2021 Dec;62(6):859-868. doi: 10.1016/j.ejvs.2021.08.033. Epub 2021 Oct 27.
- Results publication: PubMed 32276017Gallitto E, Faggioli G, Vacirca A, Pini R, Mascoli C, Fenelli C, Logiacco A, Abualhin M, Gargiulo M. The benefit of combined carbon dioxide automated angiography and fusion imaging in preserving perioperative renal function in fenestrated endografting. J Vasc Surg. 2020 Dec;72(6):1906-1916. doi: 10.1016/j.jvs.2020.02.051. Epub 2020 Apr 8.
- Results publication: PubMed 34369173Chisci E, Michelagnoli S, Masciello F, Turini F, Panci S, Troisi N. Benefits and Role of Carbon Dioxide Angiography in Case of Misalignment Between Fenestration and Target Vessel During Fenestrated Endovascular Aneurysm Repair. J Endovasc Ther. 2022 Feb;29(1):7-10. doi: 10.1177/15266028211032955. Epub 2021 Aug 8.
- Results publication: PubMed 30745030Geisbusch S, Kuehnl A, Salvermoser M, Reutersberg B, Trenner M, Eckstein HH. Editor's Choice - Hospital Incidence, Treatment, and In Hospital Mortality Following Open and Endovascular Surgery for Thoraco-abdominal Aortic Aneurysms in Germany from 2005 to 2014: Secondary Data Analysis of the Nationwide German DRG Microdata. Eur J Vasc Endovasc Surg. 2019 Apr;57(4):488-498. doi: 10.1016/j.ejvs.2018.10.030. Epub 2019 Feb 7.
- Results publication: PubMed 27575304de Lachomette MF, Della N, Maucort-Boulch D, Duprey A, Rosset E, Feugier P, Lermusiaux P, Albertini JN, Millon A. Renal Function after Fenestrated or Branched Endovascular Aortic Repair: The Early Impairment Predictive Factors. Ann Vasc Surg. 2017 Apr;40:1-9. doi: 10.1016/j.avsg.2016.06.014. Epub 2016 Aug 27.
- Individual participant dataSharing planned: No
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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.
Giuseppe Asciutto, MD, PhD principal investigator
Uppsala University
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoabdominal Aortic Aneurysm, run by Uppsala University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Asciutto, MD, PhD (+46 727 045645, giuseppe.asciutto@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: at the time the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103942, which also lists 12 linked publications.
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 27 Oct 2023.