ANEUFIX for Endoleaks Type II

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 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

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