Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter.

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 7, 2017

Primary Completion Date

July 18, 2018

Study Completion Date

March 29, 2023

Conditions
Femoropopliteal Occlusive DiseasePeripheral Artery Disease
Interventions
DEVICE

Kanshas DCB

The appropriate Kanshas DCB size is selected after review of the patient's baseline angiogram and determination of the reference vessel diameter and lesion length. The balloons is sized to ensure the full length of the lesion is treated. The initial inflation of the study device should be approximately 1 minute for optimal drug release. In order to optimize lesion dilatation, longer inflation times are possible at the discretion of the operator.

Trial Locations (6)

Unknown

AZ Imelda, Bonheiden

AZ Sint Blasius, Dendermonde

Klinikum Hochsauerland Gmbh, Arnsberg

Uni-Herzzentrum, Bad Krozingen

Ev Luth Diakonissenanstalt, Flensburg

RoMed Klinikum, Rosenheim

All Listed Sponsors
lead

Terumo Europe N.V.

INDUSTRY

NCT02939924 - Treatment of Patients With Lesions in the Superficial Femoral and/ or Popliteal Arteries Using Kanshas Paclitaxel-coated Balloon Catheter. | Biotech Hunter | Biotech Hunter