AneuFix - Prophylactic Sac Filling
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Abdominal Aortic Aneurysm
- Endoleak
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The current study is a follow-up study on the previous feasibility study where ACP-T5 was used. After increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study is a pilot study that (1) evaluates the technical feasibility of the prophylactic use of AneuFix during EVAR implentation and (2) assesses the rate of endoleaks after EVAR in 5 patients.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries. ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injecti...
The investigational device is called ANEUFIX, which is a product treating the endoleak by blockage of backflowing blood vessels, i.e. by filling the endoleak void and nidus of feeding artery and exit of existing draining arteries. ANEUFIX is a polymer that cures rapidly (7 min at 37°C) after injection into the AAA-sac close to the nidus.
Tracking Information
- NCT #
- NCT04307992
- Collaborators
- Trium Clinical Consulting
- Investigators
- Principal Investigator: Arjan WJ Hoksbergen, Dr VUmc Heelkunde, Amsterdam
Get Well Soon