AneuFix - Prophylactic Sac Filling

NCT04307992 | Recruiting DMC

• 1 other identifier: Triplemed 003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; Endoleak

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Intraoperative occurrence of complications

  24 hours

• Peri-operative complications

  30 days

• Prevention of (any type of) endoleak

  1, 6 and 12 months

• adverse events

  1, 6 and 12 months

• Re-interventions

  1, 6 and 12 months

Study Arms (1)

Intervention

EXPERIMENTAL

Device: ANEUFIX

Device: Prophylactic sac filling with AneuFix

Interventions

Prophylactic sac filling with AneuFix 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• patent lumbar AND a cross-sectional area at the location of the IMA (CSAIMA) \>17,5cm2 OR
• patent lumbars AND a CSAIMA \>15cm2 OR
• patent lumbars AND a CSAIMA \>12,5 cm2 OR
• patent lumbars AND a CSAIMA \>10 cm2 OR
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TripleMed B.V.: lead

Study Sites (1)

VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (2)

• Smorenburg SPM, Lely RJ, Jongkind V, Groeneveld ME, de Vries AC, Brom HLF, Jacobs MJ, Hoksbergen AWJ. First in Human Aortic Aneurysm Sac Filling with AneuFix Injectable Polymer during Endovascular Aneurysm Repair. Eur J Vasc Endovasc Surg. 2025 Dec 29:S1078-5884(25)01317-6. doi: 10.1016/j.ejvs.2025.12.048. Online ahead of print.

  PMID: 41475431 DERIVED

• 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.

  PMID: 39009453 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Arjan WJ Hoksbergen, Dr

  VUmc Heelkunde, Amsterdam

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The current study is a follow-up study on the previous feasibility study where ACP-T5 was used. After increasing the % tantalum in ANEUFIX to make the product more detectable under X-ray, the current study is a pilot study that (1) evaluates the technical feasibility of the prophylactic use of AneuFix during EVAR implentation and (2) assesses the rate of endoleaks after EVAR in 5 patients.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: February 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

NL (1)