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