Frequency of Embolic ComplicationsNCT05643664
The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms
A study testing prosthetics of the abdominal aorta and prosthetics of the abdominal aorta after determining the safe zones of clamping in people with Frequency of Embolic Complications and Frequency of Ischemic Complications, run by Meshalkin Research Institute of Pathology of Circulation at 4 sites in Russia.
Trial summary
"Pilot randomized prospective clinical study of the effectiveness of the use of artificial intelligence in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms." Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Frequency of Embolic Complications, Frequency of Ischemic Complications
- What is being tested?
- prosthetics of the abdominal aorta and prosthetics of the abdominal aorta after determining the safe zones of clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery.
- Patients who have agreed to participate in this study
Who cannot join
- Chronic heart failure of functional class III -IV according to NYHA classification;
- Chronic decompensated "pulmonary" heart;
- Severe hepatic or renal insufficiency (bilirubin >35 mmol/l, glomerular filtration rate <60 ml/min);
- Polyvalent drug allergy;
- Malignant oncological diseases in the terminal stage with a predicted life span of up to 6 months;
- Acute cerebrovascular accident;
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
Alexander A Gostev
Novosibirsk, Novosibirskaya Obl, 630005
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, 630055
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
E. Meshalkin National Medical Research Center
Novosibirsk
About this study
Official title: "Pilot Randomized Prospective Clinical Study of the Effectiveness of the Use of Artificial Intelligence in Determining the "Safe" Clamping Zones in the Surgical Treatment of Abdominal Aortic Aneurysms
"Pilot randomized prospective clinical study of the effectiveness of the use of artificial intelligence in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms."
Read the detailed description
Abdominal aortic aneurysm is a life-threatening disease, a formidable complication of which is an aneurysm rupture (Editor's Choice - European Society for Vascular Surgery). The main method of treating aneurysms is surgical reconstruction, including open or endovascular intervention ((ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms). Anatomical features of aneurysms and the presence of intraluminal thrombomass are among the criteria in deciding on the tactics of surgical treatment. These factors carry additional technical difficulties and lead to the development of intraoperative complications, including ischemic ones. Ischemia of the lower extremities is the most common complication and can be caused by thrombosis, embolism or dissection of the aortic wall (occurs in 7% of patients) (Complications Associated with Aortic Aneurysm Repair).
Thus, in order to reduce the frequency of embolic complications, it is important for the surgeon to determine a "safe" zone for applying a clamp to the aorta and main vessels. Thus, artificial intelligence (AI) can be used to interpret and analyze images of aneurysms that allow automatic quantitative measurements and determination of the exact characteristics of morphology and hydrodynamics, as well as the presence of intraluminal blood clots and calcifications. Analysis based on artificial intelligence can lead to the development of computational programs for predicting the development of aneurysms and the risk of their rupture, as well as postoperative outcomes. Artificial intelligence can also be used to determine the "safe" areas of aortic clamping. (Artificial intelligence in abdominal aortic aneurysm).
Adam and co-authors trained a neural network to detect and estimate the maximum outer diameter of aneurysms using a database of 489 CT angiographs of abdominal aortic aneurysms. AI has achieved a level of performance and accuracy suitable for clinical practice, and with the use of more CT images, further improvement in accuracy is expected (Pre-surgical and Post-surgical Aortic Aneurysm Maximum Diameter Measurement: Full Automation by Artificial Intelligence). In a study by Fujiwara et al. 145 non-contrast CT scans with suspected aneurysm were retrospectively collected. Initially, AI was trained by manually segmenting CT images. Image processing was used to determine the abdominal aortic aneurysm area and to automatically measure the size. This method has shown that AI is a useful tool for fully automatic detection and measurement of aneurysm diameter. (Fully automatic detection and measurement of abdominal aortic aneurysm using artificial intelligence). Florent Lalys and his coauthor. an automatic fast and universal algorithm for determining an intraluminal thrombus was developed. The method was tested on pre- and postoperative CT scans of the abdominal aorta and iliac artery of 145 patients and consists in determining the central line and segmentation of the aortic lumen, an optimized stage of pretreatment and the use of a 3D model (Generic thrombus segmentation from pre- and post-operative CTA).
Taking into account the references already available in some studies of the use of artificial intelligence for the treatment of cardiovascular diseases, its use is seen as a promising method for making decisions in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms, which will reduce the frequency of postoperative complications.
- Being tested
- prosthetics of the abdominal aorta, prosthetics of the abdominal aorta after determining the safe zones of clamping
- Keywords
- Aortic aneyrism, Artificial intelligence, "safe" zone of clamping, embolic complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthetics of the abdominal aortaProcedure or surgery
aneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology.
prosthetics of the abdominal aorta after determining the safe zones of clampingProcedure or surgery
aneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology. Before surgery, multispiral computed tomography data is evaluated using artificial intelligence and safe zones of aortic and arterial clampings are determined. Intraoperatively, clamping is performed in the settlement zones.
| Study group | Role | What they receive |
|---|---|---|
| Standart technology | Active comparator | the zone of aortic and main artery clamping is determined by the surgeon intraoperatively. Receives: Procedure: prosthetics of the abdominal aorta |
| Artificial intellect | Experimental | The multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" zones of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones. Receives: Procedure: prosthetics of the abdominal aorta after determining the safe zones of clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of intraoperative and early postoperative embolism
Number of intraoperative embolism according to intraoperative ultrasound monitoring. The number of developed occlusions of peripheral arteries according to ultrasound scanning
Measured: 12 months
Secondary outcomes (3)
Primary patency of the operated segment.
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment at control points
Measured: 12 months
secondary patency of the operated segment
The number of restenosis (50% or more) or reocclusion according to ultrasound duplex scanning of the operated segment after repeated intervention at control points
Measured: 12 months
MALE
The number of major adverse events that occurred in the extremities the observation period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequency of Embolic ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. In both groups, aneurysmectomy with prosthetics of the abdominal aorta is performed using the standard technology. 2. In the first group, the aortic and main artery clamping zone is determined by the surgeon intraoperatively. In the second group, before surgery, multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" areas of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643664
- Sponsor's protocol ID
- NRICP-16/11/22
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after the end of the study, receipt of the results and publication of the first data, these sections will be available to other researchers upon personal request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Pilot Randomized Prospective Clinical Study of the Effectiveness of the Use of Artificial Intelligence in Determining the "Safe" Clamping Zones in the Surgical Treatment of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT05643664
- Acronym / sponsor ID
- NRICP-16/11/22
- Keywords
- Aortic aneyrism, Artificial intelligence, "safe" zone of clamping, embolic complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Dec 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.
"Pilot randomized prospective clinical study of the effectiveness of the use of artificial intelligence in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms."
Detailed description
Abdominal aortic aneurysm is a life-threatening disease, a formidable complication of which is an aneurysm rupture (Editor's Choice - European Society for Vascular Surgery). The main method of treating aneurysms is surgical reconstruction, including open or endovascular intervention ((ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms). Anatomical features of aneurysms and the presence of intraluminal thrombomass are among the criteria in deciding on the tactics of surgical treatment. These factors carry additional technical difficulties and lead to the development of intraoperative complications, including ischemic ones. Ischemia of the lower extremities is the most common complication and can be caused by thrombosis, embolism or dissection of the aortic wall (occurs in 7% of patients) (Complications Associated with Aortic Aneurysm Repair).
Thus, in order to reduce the frequency of embolic complications, it is important for the surgeon to determine a "safe" zone for applying a clamp to the aorta and main vessels. Thus, artificial intelligence (AI) can be used to interpret and analyze images of aneurysms that allow automatic quantitative measurements and determination of the exact characteristics of morphology and hydrodynamics, as well as the presence of intraluminal blood clots and calcifications. Analysis based on artificial intelligence can lead to the development of computational programs for predicting the development of aneurysms and the risk of their rupture, as well as postoperative outcomes. Artificial intelligence can also be used to determine the "safe" areas of aortic clamping. (Artificial intelligence in abdominal aortic aneurysm).
Adam and co-authors trained a neural network to detect and estimate the maximum outer diameter of aneurysms using a database of 489 CT angiographs of abdominal aortic aneurysms. AI has achieved a level of performance and accuracy suitable for clinical practice, and with the use of more CT images, further improvement in accuracy is expected (Pre-surgical and Post-surgical Aortic Aneurysm Maximum Diameter Measurement: Full Automation by Artificial Intelligence). In a study by Fujiwara et al. 145 non-contrast CT scans with suspected aneurysm were retrospectively collected. Initially, AI was trained by manually segmenting CT images. Image processing was used to determine the abdominal aortic aneurysm area and to automatically measure the size. This method has shown that AI is a useful tool for fully automatic detection and measurement of aneurysm diameter. (Fully automatic detection and measurement of abdominal aortic aneurysm using artificial intelligence). Florent Lalys and his coauthor. an automatic fast and universal algorithm for determining an intraluminal thrombus was developed. The method was tested on pre- and postoperative CT scans of the abdominal aorta and iliac artery of 145 patients and consists in determining the central line and segmentation of the aortic lumen, an optimized stage of pretreatment and the use of a 3D model (Generic thrombus segmentation from pre- and post-operative CTA).
Taking into account the references already available in some studies of the use of artificial intelligence for the treatment of cardiovascular diseases, its use is seen as a promising method for making decisions in determining "safe" clamping zones in the surgical treatment of abdominal aortic aneurysms, which will reduce the frequency of postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. In both groups, aneurysmectomy with prosthetics of the abdominal aorta is performed using the standard technology. 2. In the first group, the aortic and main artery clamping zone is determined by the surgeon intraoperatively. In the second group, before surgery, multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" areas of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones.
| Arm | Type | Receives |
|---|---|---|
| Standart technology | Active comparator | Procedure: prosthetics of the abdominal aortathe zone of aortic and main artery clamping is determined by the surgeon intraoperatively. |
| Artificial intellect | Experimental | Procedure: prosthetics of the abdominal aorta after determining the safe zones of clampingThe multispiral computed tomography data is evaluated using artificial intelligence and the definition of "safe" zones of aortic and main artery clamping is performed. Intraoperatively, clamping is performed in the settlement zones. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery.
- Patients who have agreed to participate in this study
Key exclusion criteria (6 listed)
- Chronic heart failure of functional class III -IV according to NYHA classification;
- Chronic decompensated "pulmonary" heart;
- Severe hepatic or renal insufficiency (bilirubin >35 mmol/l, glomerular filtration rate <60 ml/min);
- Polyvalent drug allergy;
- Malignant oncological diseases in the terminal stage with a predicted life span of up to 6 months;
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 |
|---|---|---|
| prosthetics of the abdominal aortaaneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology. | Procedure or surgery | Standart technology |
| prosthetics of the abdominal aorta after determining the safe zones of clampinganeurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology. Before surgery, multispiral computed tomography data is evaluated using artificial intelligence and safe zones of aortic and arterial clampings are determined. Intraoperatively, clamping is performed in the settlement zones. | Procedure or surgery | Artificial intellect |
Primary outcome
frequency of intraoperative and early postoperative embolism
Time frame: 12 months
Number of intraoperative embolism according to intraoperative ultrasound monitoring. The number of developed occlusions of peripheral arteries according to ultrasound scanning
3 secondary outcomes
Primary patency of the operated segment.
Time frame: 12 months
secondary patency of the operated segment
Time frame: 12 months
MALE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Yes. after the end of the study, receipt of the results and publication of the first data, these sections will be available to other researchers upon personal request.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prosthetics of the abdominal aorta and prosthetics of the abdominal aorta after determining the safe zones of clamping in people with Frequency of Embolic Complications and Frequency of Ischemic Complications, run by Meshalkin Research Institute of Pathology of Circulation at 4 sites in Russia.
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 6 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia. 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 Andrey A Karpenko, PhD (+79139504100, andreikarpenko@rambler.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of intraoperative and early postoperative embolism (time frame: 12 months). 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 15 Dec 2022.