Scientific Evidence

2. In vitro centreline crossing confirmatory study

Results

75 crossings were attempted by 3 vascular surgeons, 25 crossings each. Participants tried crossing the CTO by inflating the IntraCross Catheter balloon as close to the CTO cap as possible. Analysis from measurements from 69* successful crossings showed a mean radius of 1.4 mm and a median radius of 1.0 mm.
*failed attempts were due to a single surgeon, out of three, who reported vision difficulties on the day of the experiments.

Conclusions

Centreline crossing has been confirmed as a key attribute of the device, as it implies intraluminal crossing – a major objective during CTO crossing.

Figure 2. Depiction of the method used for documenting balloon centering and measuring the distance of the inner shaft tip from the centre of the vessel
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