Safety and effectiveness of bycross rotational atherectomy and aspiration device: a prospective, multi-center pre-market approval study

CVIR Endovascular

Table 6 Secondary safety endpoint data

Adverse events count:
Post-procedure SAE/MAE	0% (0/41)
Discharge day SAE/MAE	9.5% (4/41)
30-Day SAE/MAE	0% (0/41)^a
6-Month	2.4% (1/41)^a
Adverse events type
Restenosis of target lesion	2
Restenosis of target vessel	2
Restenosis of another vessel	1

^a 30-Day and 6-Month follow up does not include to subject who was lost to follow up