AneuFix - Prophylactic Sac Filling

TripleMed

Status: Enrolling

Conditions: Endoleak; Abdominal Aortic Aneurysm

Treatments: Device: Prophylactic sac filling with AneuFix

Study type: Interventional

Funder types: Industry

Identifiers

NCT04307992

Triplemed 003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Intervention

Experimental group

Description:

Device: ANEUFIX

Treatment:

Device: Prophylactic sac filling with AneuFix