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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.
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 (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Device: ANEUFIX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic sac filling with AneuFix | Device | ANEUFIX is administered by injection into the AAA via transferal access at the time of EVAR placement using imaging techniques to guide the place of injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | 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 | 24 hours |
| Clinical Success rate | 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 | 6 months |
| Clinical Success rate | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative occurrence of complications | Adverse events occurring during the surgical intervention are registered. | 24 hours |
| Peri-operative complications | Rate of peri-operative complications |
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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:
- Open IMA AND
Infrarenal neck according to the IFU of the EVAR device
Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the EVAR device to be used
Patient having a life expectation of at least 2 years
Being older than 18 years
Willing and able to comply with the requirements of this clinical study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florie Daniels | Contact | +31 6 38 19 92 91 | f.daniels@triple-med.com | |
| Tjeerd Homsma | Contact | +31 6 29 07 80 03 | t.homsma@triple-med.com |
| Name | Affiliation | Role |
|---|---|---|
| Arjan WJ Hoksbergen, Dr | VUmc Heelkunde, Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VUmc | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41475431 | Derived | Smorenburg SPM, Lely RJ, Jongkind V, Groeneveld ME, de Vries AC, Brom HLF, Jacobs MJ, Hoksbergen AWJ. First in Human Aortic Aneurysm Sac Filling with AneuFix Injectable Polymer during Endovascular Aneurysm Repair. Eur J Vasc Endovasc Surg. 2025 Dec 29:S1078-5884(25)01317-6. doi: 10.1016/j.ejvs.2025.12.048. Online ahead of print. | |
| 39009453 |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| 30 days |
| Prevention of (any type of) endoleak | Occurrence of (any type of) endoleak | 1, 6 and 12 months |
| adverse events | Occurrence of adverse events and adverse device effects | 1, 6 and 12 months |
| Re-interventions | Rate of secondary endovascular or surgical re-interventions | 1, 6 and 12 months |
| Aneurysm rupture | Rate of aneurysm rupture | 6 and 12 months |
| Proportion of patients surviving 24 months after treatment | Survival throughout the study up until 24 months | 24 months |
| Smorenburg SPM, Lely RJ, Jacobs MJ, Hoksbergen AWJ. Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol. BMJ Open. 2024 Jul 15;14(7):e082380. doi: 10.1136/bmjopen-2023-082380. |
| D001018 |
| Aortic Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |