IOPS Technology During Cannnulation of Contralateral Limb in EVAR

Launched by CLINICAL CENTRE OF SERBIA · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new technology called the Intra-Operative Positioning System (IOPS) to see how it can help reduce radiation exposure during a procedure called EndoVascular Aneurysm Repair (EVAR). EVAR is a minimally invasive surgery used to treat abdominal aortic aneurysms (AAA), which are bulges in the main artery that can be dangerous if they rupture. The IOPS technology allows doctors to navigate and visualize the devices used in this procedure in 3D, which could make the surgery safer for patients and healthcare providers by reducing their exposure to harmful radiation.

To participate in this study, you need to be an adult over 18 years old with a specific type of AAA that is not ruptured or symptomatic. Unfortunately, those who are pregnant, younger than 40, have more complicated types of aneurysms, or are undergoing open surgery or more advanced treatments won't be eligible. If you join the trial, you can expect to have the standard EVAR procedure with the added benefit of this new technology, which aims to improve safety and precision during surgery. This study is set to start between September 2024 and May 2025, and it's an important step toward making these life-saving procedures even safer for everyone involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - 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
• Exclusion Criteria:
• • 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.