IOPS Technology During Cannnulation of Contralateral Limb in EVAR

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-100
SponsorClinical Centre of Serbia

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intra-Operative Positioning System (IOPS)

    Device

    This 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

    Device

    This group will be treated using standardised materials (wires, catheters) during EVAR.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: IOPS group1 intervention
Group B: Conventional group1 intervention

Trial outcomes

Primary outcomes

1

Fluoroscopic time per participant required for cannulation

Record cumulative fluoroscopy time reported by fluoroscopic system before and after cannulation of contralateral limb

Time frame
Cannulation of contralateral limb during the intervention
2

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

Time frame
Cannulation of contralateral limb during the intervention

Secondary outcomes

1

Clock time per participant required for cannulation

Use stopwatch, or record clock time before and after cannulation of contralateral limb

Time frame
Cannulation of contralateral limb during the intervention
2

Radiation dose per participant during cannulation

Cumulative air kerma \[CAK\], air kerma area product \[KAP\], excluding digital subtraction angiography time

Time frame
Record radiation reported by fluoro system before and after cannulation of contralateral limb during the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinical Centre of Serbia

Lead sponsor

Centerline Biomedical, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: