Brief Title
ANEUFIX for Endoleak Type II Repair
Official Title
Treatment of Type II Endoleak With ANEUFIX: Assessment of Safety, Performance and Clinical Benefit.
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.
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
Primary Outcome
Technical success rate
Secondary Outcome
Absence of aneurysm sac growth
Condition
Abdominal Aortic Aneurysm
Intervention
ANEUFIX
Study Arms / Comparison Groups
Intervention
Description: All patients enrolled are intended to be treated
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
25
Start Date
May 13, 2020
Completion Date
December 2023
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria:
1. Persistent type II endoleak (more than 6 months post-EVAR or post-embolization
procedure); AND
2. Volume of the 'endoleak void' can be estimated upfront; AND
3. An EVAR without circulatory complications (including the absence of an open AMI that
is connected to the endoleak as judged on existing CT-scan); AND
4. 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
5. An aneurysm sac growing in contours after EVAR of minimal 10 mm (per European
Guidelines) as documented in the preceding 90 days by means of Echo Doppler (or
alternative visualization technique) and based upon sac diameter measurements; AND
6. An aneurysm sac that can be punctured via a translumbar approach; AND
7. Possibility to withhold anti-thrombogenic medication temporarily; AND
8. Ability and willingness to undergo the translumbar procedure under local anesthaesia
in a CT scanner; AND
9. 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. Patients with an untreated open endoleak connected AMI (patients can be included if
the AMI is coild or is technically not possible to be coiled prior the Aneufix
application); OR
5. Patient with haemostatic disorder (including bleeding disorders) or who is clinically
unstable; OR
6. Patient with a too high risk of abdominal sac rupture to allow safe radiological and
scanographic assessments; OR
7. Patient who is allergic to contrast media or anticoagulants; OR
8. Patient with renal impairment (eGFR < 30 ml/min); OR
9. Patient with a contra-indication for temporal positioning of a translumbar
needle/catheter; OR
10. 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
11. Women of child-bearing potential, OR
12. Patient with a life expectancy of less than 12 months.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Arjan WJ Hoksbergen, Dr, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03918460
Organization ID
TripleMed 002
Responsible Party
Sponsor
Study Sponsor
TripleMed B.V.
Collaborators
Trium Clinical Consulting
Study Sponsor
Arjan WJ Hoksbergen, Dr, Principal Investigator, VUmc Heelkunde, Amsterdam
Verification Date
September 2022