The AneuFix  pivotal study to treat type II endoleaks was started in July 2020.

As of today 23 patients with sac growth over a period of > 6months in accordance with ESVS guidelines have been treated. In total 40 patients will be included.

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Status:

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Clinical Protocol:

 

Primary Endpoint: Technical success of Type II endoleak repair with ANEUFIX as demonstrated by the absence of endoleak circulation at the intended treated endoleak at the end of the procedure

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Secundary Endpoints:

• Absence of aneurysm sac growth at 6 and 12 months  (determination of clinical success rate via CT scans)  Growth is determined based on core lab assessments of the abdominal aortic diameter, measured anteriorposterior and the maximum diameter relative to the aneurysm;

• Documentation of intra- and peri-operative complications (<30 days);

• Occurrence of serious adverse events, vascular related adverse events and adverse device effects, complications and deaths, re-interventions, aneurysm rupture in the peri operative period.

• Occurrence of general adverse events and adverse device effects at 1, 3, 6, 12 and 24 months;

• Rate of secondary endovascular or surgical re-interventions at 1, 3, 6 and 12 months

• Rate of aneurysm rupture at 6 and 12 months;

• Survival throughout the study up until 24 months

 

Safety is assessed based on the nature and severity of adverse events

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CT-scans  are reviewed by an independant CoreLab

 

A Data Safety Monitoring Board reviews the data after 5, 15 and 25 patients treated