AneuFix - Prophylactic Sac Filling

NCT ID: NCT04307992

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-12-31

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.

Conditions

Abdominal Aortic Aneurysm; Endoleak

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Device: ANEUFIX

Group Type: EXPERIMENTAL

Prophylactic sac filling with AneuFix

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TripleMed B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arjan WJ Hoksbergen, Dr

Role: PRINCIPAL_INVESTIGATOR

VUmc Heelkunde, Amsterdam

Locations

VUmc

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Florie Daniels

Role: CONTACT

f.daniels@triple-med.com

+31 6 38 19 92 91

Tjeerd Homsma

Role: CONTACT

t.homsma@triple-med.com

+31 6 29 07 80 03

Facility Contacts

Arjan WJ Hoksbergen, Dr.

Role: primary

a.hoksbergen@amsterdamumc.nl

Stefan Smorenburg

Role: backup

s.smorenburg@amsterdamumc.nl

+31 6 22 61 28 62

References

Smorenburg SPM, Lely RJ, Jacobs MJ, Hoksbergen AWJ. Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol. BMJ Open. 2024 Jul 15;14(7):e082380. doi: 10.1136/bmjopen-2023-082380.

Reference Type: DERIVED

PMID: 39009453 (View on PubMed)

Other Identifiers

Triplemed 003

Identifier Type: -

Identifier Source: org_study_id