IOPS Technology During Cannnulation of Contralateral Limb in EVAR

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.

Conditions

• Abdominal Aortic Aneurysm
• Abdominal Aortic Aneurysm Without Rupture
• Radiation Exposure

Interventions

DEVICE

Intra-Operative Positioning System (IOPS)

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.

DEVICE

Conventional group

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

Sponsors & Collaborators

• Centerline Biomedical, Inc.

  collaborator INDUSTRY

• Clinical Centre of Serbia

  lead OTHER

Principal Investigators

• Igor Koncar, MD PhD · University Clinical Centre of Serbia

Eligibility

Min Age

40 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-20

Primary Completion

2025-09-08

Completion

2025-11-03

FDA Device

Yes

Countries

• Serbia

Study Locations