Abdominal Aortic Aneurysm, Endoleak
Conditions
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.
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 (2-4 min at 37°C) after injection into the AAA-sac close to the nidus.
Interventions
DEVICEProphylactic sac filling with AneuFix
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.
Sponsors
TripleMed B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 1 patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR * 2 patent lumbars AND a CSAIMA \>15cm2 OR * 3 patent lumbars AND a CSAIMA \>12,5 cm2 OR * 4 patent lumbars AND a CSAIMA \>10 cm2 OR * 5 patent lumbars AND a CSAIMA \>7,5 cm2 * 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
* Patient not able or willing to give written Informed Consent * Patient undergoing emergency procedures * Patient undergoing EVAR for ruptured or symptomatic AAA, * Patient with a suprarenal AAA * Patient with an inflammatory AAA (more than minimal wall thickening) * 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 * Patient in which a bilateral retroperitoneal incision is required for EVAR * Patient in which a sacrifice of both hypogastric arteries is required * Patient with anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation * Patient in which the administration of contrast agent is not possible: proved, severe systemic reaction to contrast agent * Patient with active infection present * Patients scheduled for or having received an organ transplant * Patient with limited life expectation due to other illness (\<1 year) * Patient with non-iatrogenic bleeding diathesis * Patient with connective tissue disease * Women of child-bearing potential * Patients with evidence at completion angiogram during EVAR of a type Ia or type III endoleak persistent after balloon inflation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of (any type of) endoleak | 1, 6 and 12 months | Occurrence of (any type of) endoleak |
| adverse events | 1, 6 and 12 months | Occurrence of adverse events and adverse device effects |
| Intraoperative occurrence of complications | 24 hours | Adverse events occurring during the surgical intervention are registered. |
| 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 |
| Re-interventions | 1, 6 and 12 months | Rate of secondary endovascular or surgical re-interventions |
| Peri-operative complications | 30 days | Rate of peri-operative complications |
Countries
Netherlands
Contacts
Primary ContactFlorie Daniels
Backup ContactTjeerd Homsma
Outcome results
None listed