Pivotal clinical study Endoleak type II
The AneuFix pivotal study to treat type II endoleaks was started in July 2020.
In total 25 patients with sac growth over a period of > 6months in accordance with ESVS guidelines will be included.
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
Absence of aneurysm sac growth at 3, 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(see core lab charter for its final assessment criteria);
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 independant CoreLab
A Data Safety Monitoring Board reviews the data after 5, 15 and 25 patients treated
Visualization of Type II endoleak using contrast before treatment
Filled endoleak with AneuFix at the end of treatment; flow from lumbar arteries is stopped 100%
Note: 2 patients treated successfully in the pilot study demonstrate closed endoleaks and reduction in aneurysm diameter after 30 months FU