About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients who are pregnant
Patients who are under 40 years of age
Patients who have symptomatic or ruptured AAA
Patients with more advanced AAA: juxtarenal, pararenal, suprarenal, thoracic, thoracoabdominal AAA
Trial population
Patients with infrarenal AAA undergoing standard EVAR according to the IFUs of the manufacturer will be stratified into two groups: 1. IOPS group (used during CL cannulation) 2. Conventional group (as usual using a standardised approach for EVAR)
Trial design
Cohort
Prospective
Treatments tested in this trial
Intra-Operative Positioning System (IOPS)
DeviceThis medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike. 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 console is operated by a technician under a physician's instruction. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.
Conventional group
DeviceThis group will be treated using standardised materials (wires, catheters) during EVAR.
Treatment groups
Trial outcomes
Primary outcomes
Fluoroscopic time per participant required for cannulation
Record cumulative fluoroscopy time reported by fluoroscopic system before and after cannulation of contralateral limb
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
Secondary outcomes
Clock time per participant required for cannulation
Use stopwatch, or record clock time before and after cannulation of contralateral limb
Radiation dose per participant during cannulation
Cumulative air kerma \[CAK\], air kerma area product \[KAP\], excluding digital subtraction angiography time
Sponsors and contacts
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Clinical Centre of Serbia
Lead sponsor
Centerline Biomedical, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: