Actively Recruiting
AneuFix - Prophylactic Sac Filling
Led by TripleMed B.V. · Updated on 2024-06-07
5
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
CONDITIONS
Official Title
AneuFix - Prophylactic Sac Filling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Asymptomatic, infrarenal abdominal aortic aneurysm (AAA) needing surgery with high risk of type II endoleak as per specific artery criteria
- Suitable infrarenal neck anatomy for EVAR device instructions
- Appropriate aortic-iliac anatomy for EVAR device use
- Life expectancy of at least 2 years
- Age over 18 years
- Willing and able to comply with study requirements
You will not qualify if you...
- Unable or unwilling to provide written informed consent
- Undergoing emergency procedures
- Undergoing EVAR for ruptured or symptomatic AAA
- Presence of suprarenal AAA
- Inflammatory AAA with more than minimal wall thickening
- Infrarenal neck or aortic-iliac anatomy unsuitable for EVAR
- Need for bilateral retroperitoneal incision for EVAR
- Need to sacrifice both hypogastric arteries
- Anatomical variations like horseshoe kidney or arteries needing reimplantation
- Severe systemic reaction to contrast agent preventing its use
- Active infection
- Scheduled for or received organ transplant
- Life expectancy less than 1 year due to other illnesses
- Non-iatrogenic bleeding disorders
- Connective tissue disease
- Women of child-bearing potential
- Persistent type Ia or type III endoleak after EVAR balloon inflation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
Research Team
F
Florie Daniels
CONTACT
T
Tjeerd Homsma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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