NCT02013193 - Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries | Biotech Hunter

Enrollment

105

Participants

Timeline

Start Date

January 7, 2014

Primary Completion Date

June 16, 2016

Study Completion Date

March 15, 2019

Conditions

Peripheral Artery DiseaseClaudicationAtherosclerosisArteriosclerosis

Interventions

DEVICE

Ranger DCB

After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.

DEVICE

uncoated PTA balloon

The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

Trial Locations (11)

1090

Medical University, AKH, Vienna

14000

CHU Caen Côte de Nacre, Caen

23795

Segeberger Kliniken, Bad Segeberg

31076

Clinique Pasteur Toulouse, Toulouse

35043

Universitätsklinikum, Marburg

59759

Klinikum Arnsberg, Arnsberg

60389

CardioVascular Center, Frankfurt

64283

Klinikum Darmstadt GmbH, Darmstadt

75908

Hopital Europeen Georges-Pompidou (HEGP), Paris

04103

Universitätsklinikum Leipzig, Leipzig

04289

Park-Krankenhaus, Leipzig

All Listed Sponsors

collaborator

CERES GmbH

INDUSTRY

collaborator

coreLab Black Forest GmbH

UNKNOWN

lead

Hemoteq AG

INDUSTRY