Clinical trial NCT04307992: AneuFix - Prophylactic Sac Filling
Official title: Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Endoleak
Lead sponsor: TripleMed B.V.
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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:

  - 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

Primary outcomes:
measure: Technical Success
timeFrame: 24 hours
measure: Clinical Success rate
timeFrame: 6 months
measure: Clinical Success rate
timeFrame: 12 months
Secondary outcomes:
measure: Intraoperative occurrence of complications
timeFrame: 24 hours
measure: Peri-operative complications
timeFrame: 30 days
measure: Prevention of (any type of) endoleak
timeFrame: 1, 6 and 12 months
measure: adverse events
timeFrame: 1, 6 and 12 months
measure: Re-interventions
timeFrame: 1, 6 and 12 months
measure: Aneurysm rupture
timeFrame: 6 and 12 months
measure: Proportion of patients surviving 24 months after treatment
timeFrame: 24 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VUmc
state: Noord Holland
Study officials:
affiliation: VUmc Heelkunde, Amsterdam
name: Arjan WJ Hoksbergen, Dr
role: PRINCIPAL_INVESTIGATOR
References: