AneuFix - Prophylactic Sac Filling

Not Applicable

Recruiting

• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Interventions: Device: Prophylactic sac filling with AneuFix

• Registration Number: NCT04307992
• Lead Sponsor: TripleMed B.V.

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.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-13
• Study Start: 2022-02-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Prophylactic sac filling with AneuFix	Device: ANEUFIX

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Peri-operative complications	30 days	Rate of peri-operative complications
Proportion of patients surviving 24 months after treatment	24 months	Survival throughout the study up until 24 months
Prevention of (any type of) endoleak	1, 6 and 12 months	Occurrence of (any type of) endoleak
Intraoperative occurrence of complications	24 hours	Adverse events occurring during the surgical intervention are registered.
adverse events	1, 6 and 12 months	Occurrence of adverse events and adverse device effects
Aneurysm rupture	6 and 12 months	Rate of aneurysm rupture
Re-interventions	1, 6 and 12 months	Rate of secondary endovascular or surgical re-interventions

Trial Locations

Locations (1)

VUmc; 🇳🇱 Amsterdam, Noord Holland, Netherlands