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 (7 min at 37°C) after injection into the AAA-sac
close to the nidus.
Study Type
Interventional
Primary Outcome
Technical success.
Secondary Outcome
Intraoperative occurrence of complications;
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
December 2019
Completion Date
December 2022
Primary Completion Date
December 2020
Eligibility Criteria
Inclusion Criteria:
1. Persistent type IIa or IIb 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); AND
4. An endoleak confirmed by CT scan in preceding 8 weeks demonstrating the high
likelihood of the isolated nature of the endoleak; AND
5. An aneurysm sac growing in contours after EVAR (per European Guidelines) as documented
in the preceding 8 weeks by means of echo (or alternative visualization technique) and
based upon sac diameter measurements; AND
6. An aneurysm sac that can be punctured in translumbar approach; AND
7. Possibility to withhold anti-thrombogenic medication temporarily; AND
8. Ability and willingness to undergo the translumbar procedure under local anesthesia in
a CT scanner; AND
9. Be older than 18 years.
Exclusion Criteria:
1. Patient not able or willing to give themselves written Informed Consent; OR
2. Patient undergoing emergency procedures; OR
3. Patient with traumatic vascular injury; OR
4. Patient who underwent unsuccessful previous interventions for endoleak type II (other
than AMI) with/without use of other than coiling techniques; OR
5. Patients with a known open AMI (patients can be included if the AMI is or can be
coiled prior the ANEUFIX application); OR
6. Patient with hemostatic disorder or who is clinically unstable; OR
7. Patient with a too high risk of abdominal sac rupture to allow safe radiological and
scanographic assessments; OR
8. Patient who is allergic to contrast media or anticoagulants; OR
9. Patient with renal impairment (serum creatinine > 2 mg/dl or > 176 mmol/l); 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, +32475923149, [email protected]
Administrative Informations
NCT ID
NCT03918460
Organization ID
TripleMed 002
Responsible Party
Sponsor
Study Sponsor
TripleMed B.V.
Collaborators
Fakkel bvba
Study Sponsor
Arjan WJ Hoksbergen, Dr, Principal Investigator, VUmc Heelkunde, Amsterdam
Verification Date
April 2019