NCT01947478View on ClinicalTrials.gov

MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
Femoral Artery StenosisPopliteal Artery StenosisFemoral Artery OcclusionPopliteal Artery Occlusion
Interventions
DEVICE

MDT-2113 Drug-Eluting Balloon

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

DEVICE

Standard angioplasty balloon

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Trial Locations (1)

Unknown

Kansai Rosai Hospital, Amagasaki

Sponsors
All Listed Sponsors
lead

Medtronic Endovascular

INDUSTRY

NCT01947478 - MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery | Biotech Hunter | Biotech Hunter