An interventional study of Aneufix ACP-T5 in Abdominal Aortic Aneurysm, sponsored by TripleMed B.V.. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by TripleMed B.V. · Not applicable, Interventional, and Device feasibility
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.
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'.
Exclusion Criteria:
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.
Also known as: ANEUFIX
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.
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.
Time frame: 24h
Clinical succes rate.
The clinical succes rate is defined as the absence of aneurysm sac growth after the procedure of ACP-T5 injection.
Time frame: 6 and 12 months
Safety aspects I : intra-operative complication rate.
Intra-operative occurrence of complications.
Time frame: All complications observed during the ACP-T5 injection procedure are documented.
Safety aspects II: Peri-operative complication rate.
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.
Time frame: 1 month
Safety aspects III : Mid- and long-term complication rate.
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.
Time frame: 1-12 months
Aneurysm sac rupture.
The aneurysm sac rupture rate is assessed over a period of 12 months.
Time frame: 12 months
Survival.
The survival rate throughout the study and up to 24 months is assessed.
Time frame: 24 months.
Plan to share: No — There is currently no plan to share with other investigators then those participating in the study.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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TripleMed B.V.