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Guidance system and radiation exposure during abdominal aortic aneurysm repair

Looks at radiation exposure with a 3D navigation system in abdominal aortic aneurysm repair.

Key facts

Who runs it
Clinical Centre of Serbia
Where
Serbia1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
IOPS Technology During Cannnulation of Contralateral Limb in EVAR
Status
Not yet recruiting
People taking part
80 people, planned
Started
20 Jan 2025
Planned end
3 Nov 2025
Type of study
Observational, 2 groups
Treatments tested
  • Intra-Operative Positioning System (IOPS)
  • Conventional group
Record updated
20 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an abdominal aortic aneurysm below the kidney arteries (infrarenal AAA). They must be having standard EVAR, a repair done through the blood vessels, between 1st September 2024 and 1st May 2025.

Age
40 Years to 100 Years
Sex
All
Disease stage
Infrarenal AAA without symptoms and not burst (not ruptured), caused by hardening of the arteries (atherosclerosis).
Earlier treatment
People must be having standard EVAR used as the device instructions (IFU) describe. People treated with open surgery, or only watched without a procedure, cannot join.

Main reasons for not taking part

  • Pregnancy
  • An aneurysm that causes symptoms or has burst
  • A more extensive aneurysm: juxtarenal, pararenal, suprarenal, thoracic or thoracoabdominal
  • An aneurysm not caused by atherosclerosis, such as dissection, connective tissue disorders, infection (mycotic) or injury
  • More complex repairs, such as fenestrated/branched EVAR, endostaplers, chimney EVAR or iliac branch devices

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • All patients (over 18 years of age) with infrarenal AAA treated between 1st September 2024 and 1st May 2025 undergoing standard EVAR according to the IFU

Who cannot take part

  • Patients undergoing open surgery
  • Non-atherosclerotic origin of disease: dissection, connective tissue disorders, mycotic AAA, posttraumatic AAA
  • Patients who are under 40 years of age
  • Patients who are pregnant
  • Patients who have symptomatic or ruptured AAA
  • Patients with more advanced AAA: juxtarenal, pararenal, suprarenal, thoracic, thoracoabdominal AAA
  • Patients who were treated in a conservative manner
  • Patients undergoing more advanced treatment options: fenestrated/branched EVAR, endostaplers, chimney EVAR, iliac branch devices, etc

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 100 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Short-term results are favorable for EndoVascular Aneurysm Repair (EVAR) compared to open surgery. One of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices. The use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation. Because of the harmful effects of radiation, recent radiation protection guidelines strongly recommend as low as reasonably achievable (ALARA) principle. The need for additional radiation-reducing navigation techniques is high, with the ultimate goal of performing endovascular procedures without radiation at all.

Read full original descriptionShow less

In response to these challenges, Centerline Biomedical (Cleveland, Ohio, USA) has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System (IOPS). This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.

This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb (CL) during standard EVAR.

The 2 groups in the trial

  • IOPS group

    Patients with AAA undergoing standard EVAR according to the IFU using IOPS technology for visulisation of guidewires and catheter for the cannulation of contralateral limb.

    Treatment: Intra-Operative Positioning System (IOPS)

  • Conventional group

    Patients with AAA undergoing standard EVAR according to the IFU using standardised approach and materials.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Contralateral Limb Cannulation Using Intra-Operative Positioning SystemTechnology in Endovascular Aneurysm Repair
Plain-language title
Guidance system and radiation exposure during abdominal aortic aneurysm repairGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06570785, who can take part
Record updated
20 November 2024