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Pivotal clinical study endoleak type II

The AneuFix pivotal study to treat persistent type II endoleaks was started in July 2020. As of today 57 patients with sac growth over a period of > 6 months in accordance with ESVS guidelines have been treated and enrollment has closed.

Primary Endpoint: Technical success of Type II endoleak repair with AneuFix Injectable Polymer as demonstrated by the absence of circulation at the treated endoleak at the end of the procedure.

Secondary 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. CT-scans are reviewed by an independent CoreLab. A Data Safety Monitoring Board reviews the data.

Interim results:
Technical succes*:

• In 98% of cases the endoleak could successfully be approached and filled with AneuFix polymer
• In 90.9% of cases the endoleak was successfully closed on the CT scan after 24 hrs

Clinical succes*:

• Sac stabilization or regression after 6 months FU: 87,5%

Feasibility clinical study prevention type II endoleak

More information available soon.