AneuFix - Prophylactic Sac Filling

Feasibility Assessment of the Prophylactic Use of AneuFix at the Time of EVAR Implantation

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Intervention / Treatment: Device: Prophylactic sac filling with AneuFix

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 Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florie Daniels; Phone Number: +31 6 38 19 92 91; Email: f.daniels@triple-med.com
• Study Contact Backup: Name: Tjeerd Homsma; Phone Number: +31 6 29 07 80 03; Email: t.homsma@triple-med.com

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1081 HV
      • Recruiting
      • VUmc
      • Contact: Arjan WJ Hoksbergen, Dr.; Email: a.hoksbergen@amsterdamumc.nl
      • Contact: Stefan Smorenburg; Phone Number: +31 6 22 61 28 62; Email: s.smorenburg@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Device: ANEUFIX	Device: Prophylactic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	30 days
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
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

Collaborators and Investigators

• Sponsor: TripleMed B.V.
• Collaborators: Trium Clinical Consulting
• Investigators: Principal Investigator: Arjan WJ Hoksbergen, Dr, VUmc Heelkunde, Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Endoleak
• Other Study ID Numbers: Triplemed 003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No