The Role of Artificial Intelligence in the Treatment of Abdominal Aortic Aneurysms

NCT05643664 | Unknown DMC

• 1 other identifier: NRICP-16/11/22
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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."

Conditions

Frequency of Embolic Complications; Frequency of Ischemic Complications

Keywords

Aortic aneyrism; Artificial intelligence; "safe" zone of clamping; embolic complications

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (3)

• Primary patency of the operated segment.

  12 months

• secondary patency of the operated segment

  12 months

• MALE

  12 months

Study Arms (2)

Standart technology

ACTIVE COMPARATOR

the zone of aortic and main artery clamping is determined by the surgeon intraoperatively.

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.

Procedure: prosthetics of the abdominal aorta after determining the safe zones of clamping

Interventions

prosthetics of the abdominal aorta PROCEDURE

aneurysmectomy is performed with prosthetics of the abdominal aorta using the standard technology.

Standart technology

prosthetics of the abdominal aorta after determining the safe zones of clamping PROCEDURE

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.

Artificial intellect

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with aneurysmal dilation of the abdominal aorta, who are shown surgery.
• Patients who have agreed to participate in this study

You may not qualify if:

• 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;

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (4)

Alexander A Gostev

Novosibirsk, Novosibirskaya Obl, 630005, Russia

Location

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Novosibirsk, 630055, Russia

Location

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

E. Meshalkin National Medical Research Center

Novosibirsk, Russia

Location

Central Study Contacts

Andrey A Karpenko, PhD

CONTACT

+79139504100; andreikarpenko@rambler.ru

Alexandr A Gostev, PhD

CONTACT

+79139555074; a_gostev@meshalkin.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year after the first publication
• Access Criteria: access to data on a personal request

Locations

RU (4)