Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter

PHASE3CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2019

Conditions
StenosisRestenosis
Interventions
DEVICE

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"

DEVICE

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."

Trial Locations (7)

12351

Vivantes Klinikum Neukölln, Berlin

14129

Ev. Krankenhaus Hubertus, Berlin

39120

Klinikum der Otto-von-Guericke-Universität Magdeburg, Magdeburg

39130

Klinikum Magdeburg, Magdeburg

79189

Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen

80636

Deutsches Herzzentrum München, München

83022

RoMed Klinikum Rosenheim, Rosenheim

All Listed Sponsors
lead

B. Braun Melsungen AG

INDUSTRY

NCT01970579 - Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter | Biotech Hunter | Biotech Hunter