The purpose of this study is to collect and analyze additional information about the safety and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic lesions in native coronary arteries.
This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure. The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
278
Standard catheterization procedure including Bare Metal Stent deployment.
ZNA Middelheim
Antwerp, Belgium
UZ Brussel
Brussels, Belgium
CHU Charleroi
Charleroi, Belgium
Target vessel failure (TVF)
Time frame: 270 days
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CHU de Liege
Liège, Belgium
Herz-Kreislauf-Zentrum Segeberger Kliniken
Bad Segeberg, Germany
Charité - Campus Benjamin Franklin
Berlin, Germany
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, Germany
University Hospital of Heidelberg
Heidelberg, Germany
Helios Klinkum
Siegburg, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Germany
...and 6 more locations