Status:

NOT_YET_RECRUITING

IOPS Technology During Cannnulation of Contralateral Limb in EVAR

Lead Sponsor:

Clinical Centre of Serbia

Collaborating Sponsors:

Centerline Biomedical, Inc.

Conditions:

Abdominal Aortic Aneurysm

Abdominal Aortic Aneurysm Without Rupture

Eligibility:

All Genders

40-100 years

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 e...

Detailed Description

Background: The current standard of care for abdominal aortic aneurysm (AAA) is endovascular aneurysm repair (EVAR) which has been suggested as the treatment of choice by both European and American g...

Eligibility Criteria

Inclusion

  • \- 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

  • 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.

Key Trial Info

Start Date :

January 20 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 3 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06570785

Start Date

January 20 2025

End Date

November 3 2025

Last Update

November 20 2024

Active Locations (1)

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1

Clinical Center of Serbia

Belgrade, Belgrade, Serbia, 11000