IOPS Technology During Cannnulation of Contralateral Limb in EVAR
NCT Number: NCT06570785
Acronym: IOPS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Abdominal Aortic Aneurysm|Abdominal Aortic Aneurysm Without Rupture|Radiation Exposure
Interventions: DEVICE: Intra-Operative Positioning System (IOPS)|DEVICE: Conventional group
Sponsor: Clinical Centre of Serbia
Collaborators: Centerline Biomedical, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-02
Completion Date: 2025-07-07
Locations: Clinical Center of Serbia, Belgrade, 11000, Serbia

Summary:
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.

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.

Primary Outcome Measures: Number of participants with technical success of gate catheterisation, Definition of technical success with fluoroscopy: Cannulation completed retrograde; Definition of technical success with IOPS: Cannulation completed retrograde using IOPS catheter, Cannulation of contralateral limb during the intervention|Fluoroscopic time per participant required for cannulation, Record cumulative fluoroscopy time reported by fluoroscopic system before and after cannulation of contralateral limb, Cannulation of contralateral limb during the intervention
Secondary Outcome Measures: Clock time per participant required for cannulation, Use stopwatch, or record clock time before and after cannulation of contralateral limb, Cannulation of contralateral limb during the intervention|Radiation dose per participant during cannulation, Cumulative air kerma \[CAK\], air kerma area product \[KAP\], excluding digital subtraction angiography time, Record radiation reported by fluoro system before and after cannulation of contralateral limb during the intervention