AneuFix - Prophylactic Sac Filling
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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 injection into the AAA-sac close to the nidus.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Device: ANEUFIX |
Device: Prophylactic sac filling with AneuFix
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
|
Outcome Measures
Primary Outcome Measures
- Technical Success [24 hours]
Technical Success as demonstrated by the feasibility to fill the AAA sac after EVAR during the same procedure, and by the rate of (all) endoleaks after EVAR followed by the AneuFix procedure
- Clinical Success rate [6 months]
Clinical Success as demonstrated by the occurrence of type II endoleaks at 6 months after EVAR, and aneurysmal sac growth at 6 months after EVAR
- Clinical Success rate [12 months]
Clinical Success as demonstrated by the occurrence of type II endoleaks at 12 months after EVAR, and aneurysmal sac growth at 12 months after EVAR
Secondary Outcome Measures
- Intraoperative occurrence of complications [24 hours]
Adverse events occurring during the surgical intervention are registered.
- Peri-operative complications [30 days]
Rate of peri-operative complications
- Prevention of (any type of) endoleak [3, 6 and 12 months]
Occurrence of (any type of) endoleak
- adverse events [1, 3, 6 and 12 months]
Occurrence of adverse events and adverse device effects
- Re-interventions [1, 3, 6 and 12 months]
Rate of secondary endovascular or surgical re-interventions
- Aneurysm rupture [6 and 12 months]
Rate of aneurysm rupture
- Proportion of patients surviving 24 months after treatment [24 months]
Survival throughout the study up until 24 months
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Asymptomatic, infrarenal AAA that requires surgery with a high-risk profile of developing endoleak type II in line with the recommendations of Guntner et al:
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Open IMA AND
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2 patent lumbars >2mm AND a cross-sectional area at the location of the IMA (CSAIMA) of at least 15cm2 OR 3 open lumbars AND a CSAIMA of >10cm2
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Infrarenal neck according to the IFU of the EVAR device
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Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
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Patient having a life expectation of at least 2 years
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Being older than 18 years
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Willing and able to comply with the requirements of this clinical study
Exclusion Criteria:
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Patient not able or willing to give written Informed Consent
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Patient undergoing emergency procedures
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Patient undergoing EVAR for ruptured or symptomatic AAA,
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Patient with a suprarenal AAA
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Patient with an inflammatory AAA (more than minimal wall thickening)
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Patient with an infrarenal neck unsuitable for endovascular fixation (including so called "hostile necks") or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
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Patient in which a bilateral retroperitoneal incision is required for EVAR
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Patient in which a sacrifice of both hypogastric arteries is required
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Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
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Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent
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Patient with active infection present
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Patients scheduled for or having received an organ transplant
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Patient with limited life expectation due to other illness (<1 year)
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Patient with non-iatrogenic bleeding diathesis
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Patient with connective tissue disease
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Pregnant women or planning to be
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VUmc | Amsterdam | Noord Holland | Netherlands | 1081 HV |
Sponsors and Collaborators
- TripleMed B.V.
- Trium Clinical Consulting
Investigators
- Principal Investigator: Arjan WJ Hoksbergen, Dr, VUmc Heelkunde, Amsterdam
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Triplemed 003