PREdilatation by high-pressure NC balloon catheter for better vessel preparation

Proper lesion preparation for stent implantation is considered crucial for
percutaneous coronary intervention procedure. Good lesion preparation allows
proper stent deployment and apposition, and avoiding kinking or early struts
malapposition in the area of implanted stent. However, in the past over 75% of
stents were found to not reach their intended diameter.
Nowadays, optimization of lesion preparation becomes a crucial part of PCI
procedure. If a lesion is prepared properly, the risk of malapposition is
reduced.
New vascular imaging possibilities including OCT are available that can be
employed to optimize the stent deployment first time around, avoid
malapposition and reduce the need for postdilatation. There are several methods
of lesion preparation, used by operators. Standard balloon catheter is most
common device which is used for predilatation. Cutting balloons or rotablation
are available for calcified lesions. Also, better stent apposition could be
achieved by high pressure postdilatation. In the PRE-NC Study the hypothesis
that high pressure predilatation by a
dedicated, non compliant (NC) balloon catheter could help with better lesion
preparation will be investigated. If the results of the Study demonstrate
PRE-NC Study Protocol ver 1.0 from 12.04.2013 Page 9 of 33 significant benefit
from high pressure predilatation during lesion preparation, this strategy could
become a standard part of PCI procedures in future.

Predilatation with high pressure NC balloons results in better lesion
preparation for stent implantation and fewer malappositions than
standard approach with standard balloon predilatation or direct stenting. The
risk of late stent thrombosis and need for reinterventions
in long term FU could be reduced.

1:1 randomized study, two groups - study group treated with BEO and OPN
balloons, control group treated with standard balloons.

Study group treatment:
- predilatation with BEO at least 24 atm and optionally with OPN
- coronary stent implantation (DES or BVS) - only currently marketed devices
- optionally low-pressure postdilatation with standard balloon (up to nominal
pressure)

Control group treatment:
- optionally predilatation with standard balloon according to Investigator
opinion and daily practice in the Center
- coronary stent implantation (DES or BVS) - only currently marketed devices
- optionally postdilatation with standard or NC balloon according to
Investigator opinion and daily practice in the Center

Study Group - predilatation
Target lesion preparation in study group should be performed by inflation of
BEO high pressure NC balloon catheter with pressure at least 24 atm. If this
inflation does not prepare target lesion optimally, which is defined as
residual stenosis less than 30% (visual estimation), additional predilatation
by OPN balloon catheter should be performed up to 35 atm. to obtain optimal
lesion preparation.

Control Group - predilatation
Target lesion preparation in control group could be performed by inflation of
standard balloon catheter, according to operator decision and local
practice. Direct stenting strategy in this group is possible too.

Secondary device treatment - Stenting
For the both, study and control group, stenting with commercially available, CE
marked drug eluting stent or bioresorbable vascular scaffold
should be performed.

The diameter of stent(s) selected should be as close to a 1:1 ratio vs. vessel
RVD as possible. The type of DES or BVS and the inflation
pressure/duration parameters used during stenting remain at operator
discretion.

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