ANEUFIX for Endoleak Type II Repair

Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.

The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR procedure more than 6 months ago.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm; Endoleak
• Intervention / Treatment: Device: 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): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tjeerd Homsma; Phone Number: +31 (0)6 29078003; Email: t.homsma@triple-med.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda
  • Genk, Belgium
    • Recruiting
    • ZOL
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
• Netherlands
  • Almelo, Netherlands
    • Active, not recruiting
    • ZGT
  • Amsterdam, Netherlands
    • Active, not recruiting
    • Amsterdam UMC - VUmc
  • Amsterdam, Netherlands
    • Terminated
    • OLVG
  • Arnhem, Netherlands
    • Terminated
    • Rijnstate
  • Haarlem, Netherlands
    • Active, not recruiting
    • Spaarne Gasthuis
  • Tilburg, Netherlands
    • Active, not recruiting
    • ETZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
2. An endoleak confirmed on a CT scan that should be done within 180 days prior to procedure but preferably within 90 days prior to screening demonstrating the high likelihood of the isolated nature of the endoleak; AND
3. An aneurysm sac growing after EVAR of minimal 10 mm (per European Guidelines) as documented in the preceding 90 days by means of CT-imaging (or alternative imaging techniques) and based upon sac diameter measurements; AND
4. An aneurysm sac that can be punctured via a translumbar approach; AND
5. Possibility to withhold anti-thrombogenic medication temporarily; AND
6. Ability and willingness to undergo the translumbar procedure; AND
7. Being older than 18 years.

Exclusion Criteria:

1. Patient not able or willing to give written Informed Consent; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
5. Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
6. Patient who is allergic to contrast media or anticoagulants; OR
7. Patient with renal impairment (eGFR < 30 ml/min); OR
8. Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
9. Patient who is participating in another trial with an investigational drug or medical device, or where a medical device/drug is used outside its labelling and its approved intended use; OR
10. Pre-menopausal women, OR
11. Patient with a life expectancy of less than 12 months, OR
12. Patient with an intra aneurysm systolic blood pressure > 125 mmHg

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; All patients enrolled are intended to be treated	Device: ANEUFIX; ANEUFIX is administered through translumbar injection into the AAA 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 rate	Technical success of Type II endoleak repair with Aneufix as demonstrated by the absence of endoleak circulation at the intended treated endoleak at the end of the procedure; presence or absence of the endoleak treated with ANEUFIX is verified by means of a CT scan the next day.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and peri-operative complications	Documentation of intra- and peri-operative complications	30 days
serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture	Occurrence of serious adverse events, vascular related adverse events and adverse device effects: complications and deaths, re-interventions, aneurysm rupture in the peri operative period.	During the Aneufix procedure
Survival rate	Survival throughout the study	24 months
Absence of aneurysm sac growth	Absence of aneurysm sac growth at 6, 12 and 24 months. Growth is determined based on independent core lab assessments of the abdominal aortic diameter, measured as the maximum diameter relative to the aneurysm.	6, 12 and 14 months
Occurrence of general adverse events and adverse device effects	Safety is assessed based on the nature and severity of observed adverse events	1 week and 1, 6, 12 and 24 months
Rate of re-interventions	Rate of secondary endovascular or surgical re-interventions	1, 6, 12 and 24 months
Rate of aneurysm rupture	Rate of aneurysm rupture will be observed	6,12 and 24 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): May 13, 2020
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 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 002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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