ANEUFIX for Endoleak Type II Repair

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918460
• Other study ID #: TripleMed 002
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: TripleMed B.V.
• Contact: Tjeerd Homsma
• Phone: +31 (0)6 29078003
• Email: t.homsma[@]triple-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endoleak

Intervention

Device:
• ANEUFIX
ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.

Locations

Country	Name	City	State
Belgium	Imelda	Bonheiden
Belgium	ZOL	Genk
Belgium	UZ Leuven	Leuven
Netherlands	ZGT	Almelo
Netherlands	Amsterdam UMC - VUmc	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	Rijnstate	Arnhem
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	ETZ	Tilburg

Sponsors (2)

Lead Sponsor	Collaborator
TripleMed B.V.	Trium Clinical Consulting

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intra- and peri-operative complications	Documentation of intra- and peri-operative complications	30 days
Secondary	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
Secondary	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
Secondary	Rate of re-interventions	Rate of secondary endovascular or surgical re-interventions	1, 6, 12 and 24 months
Secondary	Rate of aneurysm rupture	Rate of aneurysm rupture will be observed	6,12 and 24 months
Secondary	Survival rate	Survival throughout the study	24 months