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AneuFix - Prophylactic Sac Filling | Clinical Trials | Clareo Health

RECRUITINGNA

AneuFix - Prophylactic Sac Filling

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

NCT04307992•TripleMed B.V.

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

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

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
+7 more criteria

Locations (1)

VUmc

Amsterdam, North Holland, Netherlands

Key Dates

Start Date

February 15, 2022

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

June 7, 2024

Enrollment

ESTIMATED participants

Conditions

Abdominal Aortic AneurysmEndoleak

Interventions

Prophylactic sac filling with AneuFix

DEVICE

Contacts

Florie Daniels

CONTACT

+31 6 38 19 92 91 f.daniels@triple-med.com

Tjeerd Homsma

CONTACT

+31 6 29 07 80 03 t.homsma@triple-med.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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AneuFix - Prophylactic Sac Filling

Inclusion Criteria

Exclusion Criteria

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