153
Participants
Start Date
October 31, 2013
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2019
Paclitaxel coated balloon
"* Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD~* Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)~* Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)~* If two treatment balloons are necessary overlap between the balloon must be 10 mm~* Inflation pressure 7-10 atm~* Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting"
uncoated PTA catheter
"* Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD~* Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)~* Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)~* If two treatment balloons are necessary overlap between the balloon must be 10 mm~* Inflation pressure 7-10 atm~* Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting."
Vivantes Klinikum Neukölln, Berlin
Ev. Krankenhaus Hubertus, Berlin
Klinikum der Otto-von-Guericke-Universität Magdeburg, Magdeburg
Klinikum Magdeburg, Magdeburg
Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen
Deutsches Herzzentrum München, München
RoMed Klinikum Rosenheim, Rosenheim
B. Braun Melsungen AG
INDUSTRY