Abdominal Aortic AneurysmNCT05304026
Optimizing CO2 Injection Technique for EVAR
An observational study of Abdominal Aortic Aneurysm and Endovascular Aortic Repair, run by University of Bologna at 1 site in Italy.
Trial summary
Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endovascular Aortic Repair
- What is being tested?
- Technique 1, Technique 2 and Technique 3
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 15 Sep 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All elective patients with asymptomatic infrarenal abdominal aortic aneurysm (according to the ESVS guidelines) undergoing EVAR with automated CO2 digital subtraction angiography (DSA) from January 2021.
Who may be able to join
- Patients with asymptomatic infrarenal abdominal aortic aneurysm admitted to the S. Orsola - Malpighi Hospital for a planned EVAR procedure. All patients underwent a preoperative computed tomography angiography (CTA) with a <2mm slices.
Who cannot join
- Patients with contraindication for CO2 (cardiac septal defects, pulmonary arteriovenous malformations, pulmonary hypertension, severe emphysema)
- Patients requiring advanced aortic repair (FEVAR, BEVAR)
- Urgent cases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Bologna
Bologna, Emilia-Romagna, 40138
Enrico Gallitto, MD, PhD, +390512143288, enrico.gallitto@gmail.com
About this study
Official title: Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair
Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment.
Recent literature experiences describe the use of automated CO2 angiography in EVAR.
Read more
One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%.
In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level.
The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.
Read the detailed description
Endovascular aneurysm repair is currently a wide spread therapeutic option due to a lower 30-day morbidity/mortality compared with open repair (OR), especially in patients with high surgical risk. The routinary EVAR technique requires the use of iodinated contrast medium (ICM) which can cause contrast induced-acute kidney injure (CI-AKI). The incidence of CI-AKI after EVAR is estimated between 2% and 16% although renal insult can also be caused by microembolization, unplanned renal (or polar) artery coverage, renal artery lesion (as dissection) or post-operative inflammatory reaction.
In the past few years, several studies pointed out the importance of reducing the amount of iodinated contrast medium injected and proposed carbon dioxide (CO2) as an alternative to partially or completely replace ICM, especially in patients with preoperative chronic renal impairment.
According with the literature, manual or automatic CO2 injection provides a good quality imaging of both proximal and distal sealing zone in standard EVAR procedures and, combined with fusion imaging, allows to perform juxta and pararenal abdominal aortic aneurysm repair with fenestrated endograft reducing the total amount of ICM required to the procedure.
The most relevant limit to the use of CO2 is the inability to identify the proximal landing zone and the lowest renal artery that occurs in a significant number of cases (38.7%).
This limit could be related to the physical property of CO2 because, differently from ICM, it is a gas that does not completely fill the aortic lumen but it floats in the anterior portion of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior origin.
The automated CO2 injection is commonly performed using a pigtail catheter (5F/65mm length) placed at the renal arteries level.
The primary end point of the study is to identify an alternative and effective method of CO2 injection, using an automatic system through the digital Angiodroid injection system (Angiodroid Srl, San Lazzaro, Bologna) connected to a 5F introducer placed at the distal portion of infra-renal neck that allows the identification of the lowest renal artery.
This is a prospective, single center, observational, case-control study, in which each patient is the control of himself because during the procedure 2 angiographic CO2 techniques (angiography by pig tail vs 5 F introducer) are performed and compared.
All patients underwent a preoperative computed tomography angiography (CTA) within 3 months before the procedure. The images are analyzed using a dedicated software for vessel analysis (3Mensio TM, Vascular Imaging Bilthover, Netherlands) and the AAA volume is calculated using the same software by selecting points of the external aortic wall and internal aortic lumen from the lower renal artery to the aortic bifurcation.
The level of renal arteries and aortic bifurcation are evaluated on preoperative CTA reconstructions and matched with vertebral bone landmarks.
At the beginning of the procedure two CO2 DSA will be performed: the first one through the pigtail placed at the level of renal arteries and the second one through a 5F introducer placed at the end of the proximal sealing zone in order to identify the lowest renal artery and compare the quality of the images obtained.
The same way, at the end of the procedure after the endograft deployment, two CO2 DSA will be performed: the first one through the pigtail catheter placed at the level of renal arteries and the second one through the 5F introducer placed at the level of the contralateral iliac limb.
The investigators prospectively collect clinical and morphological preoperative, intraoperative and postoperative data as shown in the table above.
Clinical characteristics: age years, sex, hypertension (systolic blood pressure ≥140 or/and diastolic ≥90 mmHg, or specific therapy), dyslipidemia (total cholesterol ≥200 mg/dl or low density lipoprotein ≥120 mg/dl or specific therapy), diabetes mellitus (pre-diagnosed in therapy with oral hypoglycemic drugs or with insulin), current smoking, coronary artery disease (defined as a history of angina pectoris, myocardial infarction or coronary revascularization), chronic obstructive pulmonary disease (defined as chronic bronchitis or emphysema), chronic kidney disease (glomerular filtration rate <60 ml/min), dialysis, pre and post-operative creatinine serum, ASA (American Society Anesthesiologic classification), medical therapy (antiplatelet types, anticoagulant therapy, statin therapy, anti-hypertensive medical therapy).
Morphological characteristics: aneurysm diameter, aneurysm volume, aneurysm neck features according to Chaickof classification, iliac axes features according to Chaickof classification, renal arteries number and clock position, hypogastric arteries patency, aortic carrefour diameter.
Intraoperative data: anesthesia (general or spinal), vascular access (surgical or percutaneous), endograft features (bi- or tri-modular, suprarenal fixation, proximal diameter of the endograft, left and right iliac limb diameter, embolization of the aneurysmatic sac, coils number, hypogastric embolization or coverage, other adjunctive maneuvers as iliac axes stenting), type and amount of contrast medium, fluoroscopy time, dose area product (DAP) (fluoroscopy DAP, DSA DAP and total DAP), renal arteries detection at the beginning of the procedure with CO2 DSA from 5F pigtail and 5F introducer, renal and hypogastric arteries and endoleaks detection at the end of the procedure with CO2 DSA from 5F pigtail and 5F introducer (as explained before).
Post-operative data: complications related to CO2 injection rate (nausea, vomit, abdominal pain, hypotension), endoleaks at the discharge, perioperative mortality, 30-days mortality, 30-days medical or surgical complications, 30-days reintervention rate, 30-days renal function.
- Being tested
- Technique 1, Technique 2, Technique 3, Technique 4
- Keywords
- CO2, contrast medium, angiography
- 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.
Technique 1Device
It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F pigtail catheter placed at the level of renal arteries to identify the lowest renal artery.
Technique 2Device
It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F introducer placed at the end of the proximal sealing zone to identify the lowest renal artery.
Technique 3Device
It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F pigtail catheter through the pigtail catheter placed at the level of renal arteries.
Technique 4Device
It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F introducer placed at the level of the contralateral iliac limb.
| Study group | Role | What they receive |
|---|---|---|
| Population | The group includes all patients undergoing EVAR, each patient is considered as both case and control of himself as the two CO2 injection techniques, through the 5F pigtail and through the 5F introducer, are both used during the procedure. Receives: Device: Technique 1; Device: Technique 2; Device: Technique 3; Device: Technique 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic neck detection
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries in those cases when the usual technique doesn't succeed.
Measured: At the moment of CO2 injection during the procedure
Procedure success
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries, hypogastric arteries and endoleaks at the final angiography in those cases when the usual technique doesn't succeed.
Measured: At the moment of CO2 injection during the procedure
Secondary outcomes (4)
CO2 complications
Evaluate CO2 induced complications rate
Measured: within 30 days from the procedure
Mortality
Evaluate 30-day mortality related to procedure
Measured: within 30 days from the procedure
Adverse events
Assessment of any cardiopulmonary and renal events related to the procedure
Measured: within 30 days from the procedure
Rate of early reintervention
Any re-intervention needed after the procedure and the specific reason
Measured: within 30 days from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Gallitto, University of Bologna
- Investigators
- Enrico Gallitto, MD, PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304026
- Sponsor's protocol ID
- CO2 IT
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mascoli C, Faggioli G, Gallitto E, Vento V, Pini R, Vacirca A, Indelicato G, Gargiulo M, Stella A. Standardization of a Carbon Dioxide Automated System for Endovascular Aortic Aneurysm Repair. Ann Vasc Surg. 2018 Aug;51:160-169. doi: 10.1016/j.avsg.2018.01.099. Epub 2018 Mar 6.
PubMed 29522871Gallitto 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 32276017Mascoli C, Faggioli G, Gallitto E, Vento V, Indelicato G, Pini R, Vacirca A, Stella A, Gargiulo M. The Assessment of Carbon Dioxide Automated Angiography in Type II Endoleaks Detection: Comparison with Contrast-Enhanced Ultrasound. Contrast Media Mol Imaging. 2018 Mar 26;2018:7647165. doi: 10.1155/2018/7647165. eCollection 2018.
PubMed 29780288Vacirca A, Faggioli G, Mascoli C, Gallitto E, Pini R, Spath P, Logiacco A, Palermo S, Gargiulo M. CO2 Automated Angiography in Endovascular Aortic Repair Preserves Renal Function to a Greater Extent Compared with Iodinated Contrast Medium. Analysis of Technical and Anatomical Details. Ann Vasc Surg. 2022 Apr;81:79-88. doi: 10.1016/j.avsg.2021.10.039. Epub 2021 Nov 14.
PubMed 34785338
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT05304026
- Acronym / sponsor ID
- CO2 IT
- Keywords
- CO2, contrast medium, angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 31 Mar 2022 (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.
Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment.
Recent literature experiences describe the use of automated CO2 angiography in EVAR.
One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%.
In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level.
The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.
Detailed description
Endovascular aneurysm repair is currently a wide spread therapeutic option due to a lower 30-day morbidity/mortality compared with open repair (OR), especially in patients with high surgical risk. The routinary EVAR technique requires the use of iodinated contrast medium (ICM) which can cause contrast induced-acute kidney injure (CI-AKI). The incidence of CI-AKI after EVAR is estimated between 2% and 16% although renal insult can also be caused by microembolization, unplanned renal (or polar) artery coverage, renal artery lesion (as dissection) or post-operative inflammatory reaction.
In the past few years, several studies pointed out the importance of reducing the amount of iodinated contrast medium injected and proposed carbon dioxide (CO2) as an alternative to partially or completely replace ICM, especially in patients with preoperative chronic renal impairment.
According with the literature, manual or automatic CO2 injection provides a good quality imaging of both proximal and distal sealing zone in standard EVAR procedures and, combined with fusion imaging, allows to perform juxta and pararenal abdominal aortic aneurysm repair with fenestrated endograft reducing the total amount of ICM required to the procedure.
The most relevant limit to the use of CO2 is the inability to identify the proximal landing zone and the lowest renal artery that occurs in a significant number of cases (38.7%).
This limit could be related to the physical property of CO2 because, differently from ICM, it is a gas that does not completely fill the aortic lumen but it floats in the anterior portion of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior origin.
The automated CO2 injection is commonly performed using a pigtail catheter (5F/65mm length) placed at the renal arteries level.
The primary end point of the study is to identify an alternative and effective method of CO2 injection, using an automatic system through the digital Angiodroid injection system (Angiodroid Srl, San Lazzaro, Bologna) connected to a 5F introducer placed at the distal portion of infra-renal neck that allows the identification of the lowest renal artery.
This is a prospective, single center, observational, case-control study, in which each patient is the control of himself because during the procedure 2 angiographic CO2 techniques (angiography by pig tail vs 5 F introducer) are performed and compared.
All patients underwent a preoperative computed tomography angiography (CTA) within 3 months before the procedure. The images are analyzed using a dedicated software for vessel analysis (3Mensio TM, Vascular Imaging Bilthover, Netherlands) and the AAA volume is calculated using the same software by selecting points of the external aortic wall and internal aortic lumen from the lower renal artery to the aortic bifurcation.
The level of renal arteries and aortic bifurcation are evaluated on preoperative CTA reconstructions and matched with vertebral bone landmarks.
At the beginning of the procedure two CO2 DSA will be performed: the first one through the pigtail placed at the level of renal arteries and the second one through a 5F introducer placed at the end of the proximal sealing zone in order to identify the lowest renal artery and compare the quality of the images obtained.
The same way, at the end of the procedure after the endograft deployment, two CO2 DSA will be performed: the first one through the pigtail catheter placed at the level of renal arteries and the second one through the 5F introducer placed at the level of the contralateral iliac limb.
The investigators prospectively collect clinical and morphological preoperative, intraoperative and postoperative data as shown in the table above.
Clinical characteristics: age years, sex, hypertension (systolic blood pressure ≥140 or/and diastolic ≥90 mmHg, or specific therapy), dyslipidemia (total cholesterol ≥200 mg/dl or low density lipoprotein ≥120 mg/dl or specific therapy), diabetes mellitus (pre-diagnosed in therapy with oral hypoglycemic drugs or with insulin), current smoking, coronary artery disease (defined as a history of angina pectoris, myocardial infarction or coronary revascularization), chronic obstructive pulmonary disease (defined as chronic bronchitis or emphysema), chronic kidney disease (glomerular filtration rate <60 ml/min), dialysis, pre and post-operative creatinine serum, ASA (American Society Anesthesiologic classification), medical therapy (antiplatelet types, anticoagulant therapy, statin therapy, anti-hypertensive medical therapy).
Morphological characteristics: aneurysm diameter, aneurysm volume, aneurysm neck features according to Chaickof classification, iliac axes features according to Chaickof classification, renal arteries number and clock position, hypogastric arteries patency, aortic carrefour diameter.
Intraoperative data: anesthesia (general or spinal), vascular access (surgical or percutaneous), endograft features (bi- or tri-modular, suprarenal fixation, proximal diameter of the endograft, left and right iliac limb diameter, embolization of the aneurysmatic sac, coils number, hypogastric embolization or coverage, other adjunctive maneuvers as iliac axes stenting), type and amount of contrast medium, fluoroscopy time, dose area product (DAP) (fluoroscopy DAP, DSA DAP and total DAP), renal arteries detection at the beginning of the procedure with CO2 DSA from 5F pigtail and 5F introducer, renal and hypogastric arteries and endoleaks detection at the end of the procedure with CO2 DSA from 5F pigtail and 5F introducer (as explained before).
Post-operative data: complications related to CO2 injection rate (nausea, vomit, abdominal pain, hypotension), endoleaks at the discharge, perioperative mortality, 30-days mortality, 30-days medical or surgical complications, 30-days reintervention rate, 30-days renal function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population | – | Device: Technique 1, Device: Technique 2, Device: Technique 3, Device: Technique 4The group includes all patients undergoing EVAR, each patient is considered as both case and control of himself as the two CO2 injection techniques, through the 5F pigtail and through the 5F introducer, are both used during the procedure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All elective patients with asymptomatic infrarenal abdominal aortic aneurysm (according to the ESVS guidelines) undergoing EVAR with automated CO2 digital subtraction angiography (DSA) from January 2021.
Key inclusion criteria (1 listed)
- Patients with asymptomatic infrarenal abdominal aortic aneurysm admitted to the S. Orsola - Malpighi Hospital for a planned EVAR procedure. All patients underwent a preoperative computed tomography angiography (CTA) with a <2mm slices.
Key exclusion criteria (3 listed)
- Patients with contraindication for CO2 (cardiac septal defects, pulmonary arteriovenous malformations, pulmonary hypertension, severe emphysema)
- Patients requiring advanced aortic repair (FEVAR, BEVAR)
- Urgent cases
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 |
|---|---|---|
| Technique 1It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F pigtail catheter placed at the level of renal arteries to identify the lowest renal artery. | Device | Population |
| Technique 2It refers to CO2 digital subtraction angiographies performed at the beginning of the procedure through a 5F introducer placed at the end of the proximal sealing zone to identify the lowest renal artery. | Device | Population |
| Technique 3It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F pigtail catheter through the pigtail catheter placed at the level of renal arteries. | Device | Population |
| Technique 4It refers to CO2 digital subtraction angiographies performed at the end of the procedure through a 5F introducer placed at the level of the contralateral iliac limb. | Device | Population |
Primary outcome
Aortic neck detection
Time frame: At the moment of CO2 injection during the procedure
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries in those cases when the usual technique doesn't succeed.
Procedure success
Time frame: At the moment of CO2 injection during the procedure
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries, hypogastric arteries and endoleaks at the final angiography in those cases when the usual technique doesn't succeed.
4 secondary outcomes
CO2 complications
Time frame: within 30 days from the procedure
Mortality
Time frame: within 30 days from the procedure
Adverse events
Time frame: within 30 days from the procedure
Rate of early reintervention
Time frame: within 30 days from the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 29522871Mascoli C, Faggioli G, Gallitto E, Vento V, Pini R, Vacirca A, Indelicato G, Gargiulo M, Stella A. Standardization of a Carbon Dioxide Automated System for Endovascular Aortic Aneurysm Repair. Ann Vasc Surg. 2018 Aug;51:160-169. doi: 10.1016/j.avsg.2018.01.099. Epub 2018 Mar 6.
- Background: 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.
- Background: PubMed 29780288Mascoli C, Faggioli G, Gallitto E, Vento V, Indelicato G, Pini R, Vacirca A, Stella A, Gargiulo M. The Assessment of Carbon Dioxide Automated Angiography in Type II Endoleaks Detection: Comparison with Contrast-Enhanced Ultrasound. Contrast Media Mol Imaging. 2018 Mar 26;2018:7647165. doi: 10.1155/2018/7647165. eCollection 2018.
- Background: PubMed 34785338Vacirca A, Faggioli G, Mascoli C, Gallitto E, Pini R, Spath P, Logiacco A, Palermo S, Gargiulo M. CO2 Automated Angiography in Endovascular Aortic Repair Preserves Renal Function to a Greater Extent Compared with Iodinated Contrast Medium. Analysis of Technical and Anatomical Details. Ann Vasc Surg. 2022 Apr;81:79-88. doi: 10.1016/j.avsg.2021.10.039. Epub 2021 Nov 14.
Related trials for Abdominal Aortic Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
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.
Enrico Gallitto, MD, PhD principal investigator
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 and Endovascular Aortic Repair, 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 1 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 31 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrico Gallitto, MD, PhD (+390512143288, enrico.gallitto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic neck detection (time frame: At the moment of CO2 injection during the procedure). 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 NCT05304026, which also lists 4 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 31 Mar 2022.