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ANEUFIX ACP-T20 for Endoleak Type II Repair

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ClinicalTrials.gov Identifier: NCT03918460
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Fakkel bvba
Information provided by (Responsible Party):
TripleMed B.V.

Brief Summary:
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ACP-T20 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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Endoleak Device: ANEUFIX ACP-T20 Not Applicable

Detailed Description:

The investigational device is called ANEUFIX, more specifically the model ACP-T20, 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.

The ACP-T20 is a polymer that cures normothermically after injection into the AAA-sac close to the nidus.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The current study is a follow up study on the previous feasibility study where ACP-T5 was used; after increasing the % tantalum to 20 % (ACP-T20) the current study evaluates the end-points in a total of 25 patients.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Type II Endoleaks With ACP-T20: Assessment of Safety, Performance and Clinical Benefit
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
All patients enrolled are intended to be treated
Device: ANEUFIX ACP-T20
ACP-T20 is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.




Primary Outcome Measures :
  1. Technical success. [ Time Frame: 24 hours ]
    Technical success of Type II endoleak repair with Aneufix ACP-T20 as demonstrated by the absence of an endoleak at the end of the procedure; presence of endoleak is verified by means of CT scan at the end of the ACP-T20 procedure


Secondary Outcome Measures :
  1. Intraoperative occurrence of complications; [ Time Frame: 24 hours ]
    The serious adverse events occurring during the surgical intervention are registered.

  2. Serious adverse events, [ Time Frame: 1, 3, 6 and 12 month ]
    Vascular related adverse events and adverse device effects;

  3. Clinical success rate. [ Time Frame: 3, 6 and 12 months ]
    Absence of aneurysm sac growth at 3, 6 and 12 months, measured by the aneurysm sac diameter on CT scans (clinical success rate at 6 months is the ultimate end-point assessment)

  4. Peri-operative complications. [ Time Frame: 30 days ]
    Rate of peri-operative complications

  5. Re-interventions. [ Time Frame: 1, 3, 6 and 12 months ]
    Rate of secondary endovascular or surgical re-interventions

  6. Aneurysm rupture [ Time Frame: 6 and 12months ]
    Rate of aneurysm rupture

  7. Proportion of patients surviving 2-years after treatment [ Time Frame: 24 months ]
    Survival throughout the study - documentation of any cause of mortality

  8. Incidence of serious adverse events over a 2-year period after treatment. [ Time Frame: 24 months ]
    Safety is assessed based on the nature and severity of observed adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ACP-T20 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918460


Contacts
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Contact: Jaak Minten, PhD +32475923149 jaak.minten@fakkel-bvba.com
Contact: Eléonore Charlier, MSc +32477448474 eleonore.charlier@fakkel-bvba.com

Sponsors and Collaborators
TripleMed B.V.
Fakkel bvba
Investigators
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Principal Investigator: Arjan WJ Hoksbergen, Dr VUmc Heelkunde, Amsterdam

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Responsible Party: TripleMed B.V.
ClinicalTrials.gov Identifier: NCT03918460     History of Changes
Other Study ID Numbers: TripleMed 002
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications