ANEUFIX for Endoleak Type II Repair

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 Status

Device

Estimated Enrollment

25

Start Date

May 13, 2020

Completion Date

December 2023

Primary Completion Date

December 31, 2021

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, 0032 471 66 79 26, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

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

July 2021