First-In-Man clinical study Endoleak type II
The First-In-Man (FIM) study is a feasibility study executed in 2018.
4 patients were included to assess whether the AneuFix product can be safely applied, and whether AneuFix is a suitable solution for the treatment of type II endoleaks.
Intention of the AneuFix procedure is to repair type II endoleaks by filling the endoleak nidus with the in-situ curing polymer. Filling the nidus is expected to stop the blood flow from back-bleeding arteries or corresponding side branches. Stopping the blood flow to the sac prevents pressurizing the sac and this is expected to stop aneurysm sac growth
The primary end-point of the study was to demonstrate the absence of an endoleak at the end of the treatment procedure. In the first 2 treated patients the occlusion of the endoleak was only partially achieved – and considered a technical/procedural failure. In the 3rd and 4th treated patient ACP-T5 was successfully injected to repair the endoleak. This was considered a technical success.
In view of the secondary end-points, no recurrence of an endoleak has been observed in the two patients where the endoleak was considered successfully stopped at the end of the procedure. These observations would demonstrate a “clinical success”. Yet, the follow up period is too limited to make any final conclusion.
After adjustment of the injection procedure, AneuFix could be used successfully to repair existing endoleaks type 2 without any technical issue. Injection must occur under angioscopic control to avoid excessive polymer injection which potentially could enter too distal into the lumbar arteries; an increased opacity by adding 20% tantalum will further improve the detectability of the polymer during the procedure.
The experience of low back pain possibly associated with a reduced mobility, which relation to a neurological or muscle ischemic event remains unclear, improves over time after the procedure. No other safety issues, as described in the study protocol and investigator brochure (biocompatibility, EVAR puncture, creation of polymer pins, creation of new endoleaks or AAA sac rupture), were observed.
An extension of the endoleak type II study is planned to demonstrate the safety and long term feasibility of AneuFix for treatment of type II endoleaks.
Based on the favorable safety results of the polymer, additional studies are planned to investigate the treatment of endoleak type I, and the use of AneuFix to prophylacticly fill the aneurysm sac immediately after endograft placement, for patients with a high risk of developing type II endoleaks.