Prospective, multi-center, randomized trial. A maximum of 130 patients will be enrolled, in a 2:1 ratio to receive either the JACTAX LD stent or the TAXUS™ Libertè™ stent to evaluate the efficacy of the product.
The JACTAX Drug Eluting Stent has been designed to minimize the amount of polymer in contact with the vessel surface, thus potentially reducing the incidence of untoward side effects. The Juxtaposed Ablumenal Coating Process is capable of exclusive coating on the ablumenal side of pre-mounted bare metal stents. Juxtaposed Ablumenal Coating is a proprietary formulation containing a bioerodable polymer. The combination of the Juxtaposed Ablumenal Coating Process and Juxtaposed Ablumenal Coating create a unique microstructure surface, and reduces the amount of required polymer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Drug Eluting Stent
Drug Eluting Stent
Universitatsklinikum Bonn
Bonn, Germany
Cardiovascular Center Sankt Katharinen
Frankfurt, Germany
Hamburg University CardioVascular Center
Hamburg, Germany
HELIOS Klinikum
Siegburg, Germany
Krankenhaus der Barmherzigen Bruder
MACE rate at 9 months
Time frame: 9 months
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Trier, Germany