ANEUFIX for Endoleak Type II Repair

NCT03918460 | Recruiting DMC

• 1 other identifier: TripleMed 002
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Abdominal Aortic Aneurysm; Endoleak

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Absence of aneurysm sac growth

  6, 12 and 14 months

• 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

  During the Aneufix procedure

• Occurrence of general adverse events and adverse device effects

  1 week and 1, 6, 12 and 24 months

• Rate of re-interventions

  1, 6, 12 and 24 months

Study Arms (1)

Intervention

EXPERIMENTAL

All patients enrolled are intended to be treated

Device: ANEUFIX

Interventions

ANEUFIX DEVICE

ANEUFIX is administered through translumbar injection into the AAA 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:

• Persistent type II endoleak (more than 6 months post-EVAR or post-embolization procedure); AND
• 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
• 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
• An aneurysm sac that can be punctured via a translumbar approach; AND
• Possibility to withhold anti-thrombogenic medication temporarily; AND
• Ability and willingness to undergo the translumbar procedure; AND
• Being older than 18 years.

You may not qualify if:

• Patient not able or willing to give written Informed Consent; OR
• Patient undergoing emergency procedures; OR
• Patient with traumatic vascular injury; OR
• Patient with haemostatic disorder (including bleeding disorders) or who is clinically unstable; OR
• Patient with a too high risk of abdominal sac rupture to allow safe radiological and scanographic assessments; OR
• Patient who is allergic to contrast media or anticoagulants; OR
• Patient with renal impairment (eGFR \< 30 ml/min); OR
• Patient with a contra-indication for temporal positioning of a translumbar needle/catheter; OR
• 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
• Pre-menopausal women, OR
• Patient with a life expectancy of less than 12 months, OR
• Patient with an intra aneurysm systolic blood pressure \> 125 mmHg

Sponsors & Collaborators

• TripleMed B.V.: lead
• Trium Clinical Consulting: collaborator

Study Sites (9)

Imelda

Bonheiden, Belgium

RECRUITING

ZOL

Genk, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

ZGT

Almelo, Netherlands

ACTIVE NOT RECRUITING

Amsterdam UMC - VUmc

Amsterdam, Netherlands

ACTIVE NOT RECRUITING

OLVG

Amsterdam, Netherlands

TERMINATED

Rijnstate

Arnhem, Netherlands

TERMINATED

Spaarne Gasthuis

Haarlem, Netherlands

ACTIVE NOT RECRUITING

ETZ

Tilburg, Netherlands

ACTIVE NOT RECRUITING

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

Tjeerd Homsma

CONTACT

+31 (0)6 29078003; 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 evaluates the end-points in a total of 40 patients.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: May 13, 2020
• Primary Completion: August 31, 2025
• Study Completion: February 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6); BE (3)