First in Human Aortic Aneurysm Sac Filling with AneuFix Injectable Polymer during Endovascular Aneurysm Repair.
Stefan P M Smorenburg, Rutger J Lely, Vincent Jongkind...
https://pubmed.ncbi.nlm.nih.gov/41475431Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04307992
Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
Led by TripleMed B.V. · Updated on 2024-06-07
5
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of using a device called AneuFix during abdominal aortic aneurysm repair surgery to prevent a complication known as an endoleak. This study focuses on patients with asymptomatic infrarenal abdominal aortic aneurysms who have a high risk of developing type II endoleaks after endovascular aneurysm repair (EVAR). The goal is to assess how well AneuFix performs when applied prophylactically at the time of EVAR implantation. The investigational device, AneuFix, is a polymer that quickly hardens after being injected into the aneurysm sac near the blood vessels causing the endoleak. It is administered by injection through transfemoral access during EVAR, guided by imaging to ensure precise placement. This treatment aims to block backflow in the blood vessels feeding the aneurysm sac and prevent endoleaks. The study is interventional and involves a single treatment group receiving the AneuFix device. Participants will be monitored for technical success within 24 hours after the procedure and clinical success at 6 and 12 months. Researchers will track complications during surgery and in the 30 days after, the occurrence of any type of endoleak, adverse events, need for further interventions, and aneurysm rupture over 1 year. Survival will also be followed for up to 24 months. Patients will undergo imaging and clinical assessments at scheduled times to evaluate outcomes and safety throughout the study period.
CONDITIONS
Brief Title
AneuFix - Prophylactic Sac Filling
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults older than 18 years
- Asymptomatic, infrarenal abdominal aortic aneurysm requiring surgery
- High risk profile for developing type II endoleak as defined by specific patent lumbar arteries and cross-sectional area of the inferior mesenteric artery
- Infrarenal neck suitable according to the endovascular aneurysm repair (EVAR) device instructions for use
- Aortic-iliac anatomy suitable for EVAR according to device criteria
- Life expectancy of at least 2 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
- EVAR for ruptured or symptomatic abdominal aortic aneurysm
- Suprarenal abdominal aortic aneurysm
- Inflammatory abdominal aortic aneurysm with more than minimal wall thickening
- Infrarenal neck unsuitable for endovascular fixation or unsuitable aortic-iliac anatomy for EVAR
- Need for bilateral retroperitoneal incision for EVAR
- Requirement to sacrifice both hypogastric arteries
- Anatomical variations such as horseshoe kidney or arteries requiring reimplantation
- Inability to receive contrast agent due to severe systemic reaction
- Active infection
- Scheduled for or previous organ transplant
- Limited life expectancy less than 1 year due to other illness
- Non-iatrogenic bleeding diathesis
- Connective tissue disease
- Women of child-bearing potential
- Persistent type Ia or type III endoleak after balloon inflation detected during completion angiogram
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure occurs at the time of EVAR placement
Participants undergo endovascular aneurysm repair (EVAR) with prophylactic sac filling using the AneuFix device to block backflowing blood vessels by filling the aneurysm sac.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 24 months
Participants are monitored for technical and clinical success, complications, prevention of endoleak, adverse events, re-interventions, aneurysm rupture, and survival.
Visits at 24 hours, 30 days, 1 month, 6 months, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
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Research Team
F
Florie Daniels
T
Tjeerd Homsma
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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Published Research Related To This Trial
Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol.
Stefan P M Smorenburg, Rutger J Lely, Michael J Jacobs...
https://pubmed.ncbi.nlm.nih.gov/39009453