Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis

NACompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

September 15, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

January 14, 2022

Conditions
Peripheral Arterial Disease
Interventions
DEVICE

Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries

"Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization.~Luminor35®-DEB PTA catheter is applied."

DEVICE

Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter

Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied.

Trial Locations (11)

13347

Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie, Berlin

22527

Angiologikum Hamburg, Hamburg

59759

Klinikum Arnsberg Angiologie, Arnsberg

66869

Westpfalz-Klinikum GmbH Standort II Kusel, Kusel

69120

Universitätsklinikum Heidelberg, Heidelberg

76307

SRH Klinikum Karlsbad-Langensteinbach, Karlsbad-Langensteinbach

79189

Herzzentrum Bad Krozingen, Bad Krozingen

80336

Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt, München

96515

Medinos Kliniken Sonneberg, Sonneberg

04103

Universitätsklinikum Leipzig, Leipzig

07747

University Hospital Jena, Radiology, Jena

All Listed Sponsors
collaborator

iVascular S.L.U.

INDUSTRY

collaborator

KKS Netzwerk

NETWORK

lead

Jena University Hospital

OTHER

NCT02540018 - Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis | Biotech Hunter | Biotech Hunter