IOPS Technology During Cannnulation of Contralateral Limb in EVAR

NCT06570785 | Not Yet Recruiting FDA Device

• 1 other identifier: IOPS study
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Abdominal Aortic Aneurysm; EndoVascular Aneurysm Repair; Radiation Protection

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Clock time per participant required for cannulation

  Cannulation of contralateral limb during the intervention

• Radiation dose per participant during cannulation

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

Study Arms (2)

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.

Device: Intra-Operative Positioning System (IOPS)

Conventional group

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

Device: Conventional group

Interventions

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.

IOPS group

Conventional group DEVICE

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

Conventional group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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)

You may qualify if:

• \- 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

You may not qualify if:

• 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
• Non-atherosclerotic origin of disease: dissection, connective tissue disorders, mycotic AAA, posttraumatic AAA
• Patients who were treated in a conservative manner
• Patients undergoing open surgery
• Patients undergoing more advanced treatment options: fenestrated/branched EVAR, endostaplers, chimney EVAR, iliac branch devices, etc.

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• Centerline Biomedical, Inc.: collaborator

Study Sites (1)

Clinical Center of Serbia

Belgrade, Belgrade, 11000, Serbia

Location

Related Publications (8)

• Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.

  PMID: 38307694 BACKGROUND

• Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.

  PMID: 29268916 BACKGROUND

• Antoniou GA, Antoniou SA, Torella F. Editor's Choice - Endovascular vs. Open Repair for Abdominal Aortic Aneurysm: Systematic Review and Meta-analysis of Updated Peri-operative and Long Term Data of Randomised Controlled Trials. Eur J Vasc Endovasc Surg. 2020 Mar;59(3):385-397. doi: 10.1016/j.ejvs.2019.11.030. Epub 2019 Dec 30.

  PMID: 31899100 BACKGROUND

• Zlatanovic P, Davidovic L, Mascia D, Ancetti S, Yeung KK, Jongkind V, Viitala H, Venermo M, Wiersema A, Chiesa R, Gargiulo M. Acute kidney injury in patients undergoing endovascular or open repair of juxtarenal or pararenal aortic aneurysms. J Vasc Surg. 2024 Jun;79(6):1347-1359.e3. doi: 10.1016/j.jvs.2024.02.021. Epub 2024 Feb 22.

  PMID: 38395093 BACKGROUND

• Modarai B, Haulon S, Ainsbury E, Bockler D, Vano-Carruana E, Dawson J, Farber M, Van Herzeele I, Hertault A, van Herwaarden J, Patel A, Wanhainen A, Weiss S, Esvs Guidelines Committee, Bastos Goncalves F, Bjorck M, Chakfe N, de Borst GJ, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kakkos SK, Koncar IB, Kolh P, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Document Reviewers, Bacher K, Brountzos E, Fanelli F, Fidalgo Domingos LA, Gargiulo M, Mani K, Mastracci TM, Maurel B, Morgan RA, Schneider P. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on Radiation Safety. Eur J Vasc Endovasc Surg. 2023 Feb;65(2):171-222. doi: 10.1016/j.ejvs.2022.09.005. Epub 2022 Sep 18. No abstract available.

  PMID: 36130680 BACKGROUND

• Finnesgard EJ, Simons JP, Jones DW, Judelson DR, Aiello FA, Boitano LT, Sorensen CM, Nguyen TT, Schanzer A. Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair. J Vasc Surg. 2023 Apr;77(4):975-981. doi: 10.1016/j.jvs.2022.11.041. Epub 2022 Nov 13.

  PMID: 36384183 BACKGROUND

• Klaassen J, Hazenberg CEVB, Bloemert-Tuin T, Wulms SCA, Teraa M, van Herwaarden JA. Editor's Choice - Radiation Dose Reduction During Contralateral Limb Cannulation Using Fiber Optic RealShape Technology in Endovascular Aneurysm Repair. Eur J Vasc Endovasc Surg. 2024 Apr;67(4):594-600. doi: 10.1016/j.ejvs.2023.10.041. Epub 2023 Nov 3.

  PMID: 37925100 BACKGROUND

• Muluk SC, Elrakhawy M, Chess B, Rosales C, Goel V. Successful endovascular treatment of severe chronic mesenteric ischemia facilitated by intraoperative positioning system image guidance. J Vasc Surg Cases Innov Tech. 2021 Nov 22;8(1):60-65. doi: 10.1016/j.jvscit.2021.11.001. eCollection 2022 Mar.

  PMID: 35118217 BACKGROUND

Related Links

• Link to the further description of IOPS technology

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Igor Koncar, MD PhD

  University Clinical Centre of Serbia

  STUDY CHAIR

Central Study Contacts

Petar Zlatanovic, MD PhD FEBVS

CONTACT

+381668300278; petar91goldy@gmail.com

Igor Koncar, MD PhD

CONTACT

+381668300290; dr.koncar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator MD PhD FEBVS

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: January 20, 2025
• Primary Completion: September 8, 2025
• Study Completion: November 3, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

SE (1)