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ANEUFIX for Endoleaks Type II (ACP-T5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02487290
Recruitment Status : Active, not recruiting
First Posted : July 1, 2015
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Fakkel bvba
Information provided by (Responsible Party):
TripleMed B.V.

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: Aneufix ACP-T5 Not Applicable

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'.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a feasibility study, where initially 5 patients are to be treated.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility Study of Treatment Type II Endoleaks With ACP-T5: a Novel Approach.
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : February 1, 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Treatment
Aneufix ACP-T5
Device: Aneufix ACP-T5
The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.
Other Name: ANEUFIX




Primary Outcome Measures :
  1. 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. [ Time Frame: 24h ]
    At the end of the injection procedure, the technical success will be determined by angiographic recording and physician assessment of absence of endoleak. CT scan at 24 hrs is obtained to reconfirm the absence of endoleak.


Secondary Outcome Measures :
  1. Clinical succes rate. [ Time Frame: 6 and 12 months ]
    The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.

  2. Safety aspects I : intra-operative complication rate. [ Time Frame: All complications observed during the ACP-T5 injection procedure are documented. ]
    Intra-operative occurrence of complications.

  3. Safety aspects II: Peri-operative complication rate. [ Time Frame: 1 month ]
    All complications as well as the occurrence of adverse events and adverse device effects during the period of 24 hrs - 1 month are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.

  4. Safety aspects III : Mid- and long-term complication rate. [ Time Frame: 1-12 months ]
    All complications as well as the occurrence of adverse events and adverse device effects during the period of 1-12 months are observed, documented, adjudicated and reported. adverse device effects are observed, documented, adjudicated and reported.

  5. Aneurysm sac rupture. [ Time Frame: 12 months ]
    The aneurysm sac rupture rate is assessed over a period of 12 months.

  6. Survival. [ Time Frame: 24 months. ]
    The survival rate throughout the study and up to 24 months is assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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 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.

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): NCT02487290


Locations
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Netherlands
Medisch Centrum Westeinde
Den Haag, Netherlands, 2512
Spaarne Gasthuisberg
Haarlem, Netherlands, 2035 RC
Sponsors and Collaborators
TripleMed B.V.
Fakkel bvba
Investigators
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Principal Investigator: Daniel Eefting, Dr Medisch Centrum Westeinde Den Haag
Principal Investigator: Erik Vermeulen, Dr Spaarne Gasthuis Haarlem

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Responsible Party: TripleMed B.V.
ClinicalTrials.gov Identifier: NCT02487290     History of Changes
Other Study ID Numbers: TripleMed 001
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share with other investigators then those participating in the study.

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

Keywords provided by TripleMed B.V.:
AAA
Endoleak

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