Brief Title
ANEUFIX for Endoleaks Type II
Official Title
Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
Brief Summary
The study is a non-randomized, multi-center safety and feasibility trial of Aneufix ACP-T5 to
treat patients with Isolated type II endoleak in the presence of a non-shrinking AAA sac
following an EVAR procedure.
Detailed Description
The investigational device is called Aneufix, more specifically the model ACP-T5, 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'.
Study Type
Interventional
Primary Outcome
Technical success of Type II endoleak repair with Aneufix ACP-T5 as demonstrated by the absence of an endoleak at the end of the procedure.
Secondary Outcome
Clinical succes rate.
Condition
Abdominal Aortic Aneurysm
Intervention
Aneufix ACP-T5
Study Arms / Comparison Groups
Treatment
Description: Aneufix ACP-T5
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
4
Start Date
February 26, 2018
Completion Date
December 2020
Primary Completion Date
February 1, 2019
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 determined upfront; AND
3. An EVAR without circulatory complications; AND
4. An endoleak confirmed by CT scan in preceding 6 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 6 weeks by means of echo (or alternative visualization technique);
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 scan; AND
9. Be 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 hemostatic disorder 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 (serum creatinine > 2 mg/dl or > 176 mmol/l); OR
8. Patient who is participating in another trial with an investigational drug or medical
device; OR
9. Women of child-bearing potential; OR
10. Patient with a life expectancy of less than 12 months.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniel Eefting, Dr, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT02487290
Organization ID
TripleMed 001
Responsible Party
Sponsor
Study Sponsor
TripleMed B.V.
Collaborators
Fakkel bvba
Study Sponsor
Daniel Eefting, Dr, Principal Investigator, Medisch Centrum Westeinde Den Haag
Verification Date
April 2019