NCT01566461View on ClinicalTrials.gov

IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)

NACompletedINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

February 28, 2014

Study Completion Date

May 31, 2018

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

Drug-Coated Balloon (DCB)

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

DEVICE

PTA Balloon: Balloon Angioplasty

Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Trial Locations (2)

94538

Washington Hospital, Fremont

96819

Kaiser Permanente Hawaii, Honolulu

Sponsors
All Listed Sponsors
lead

Medtronic Endovascular

INDUSTRY

NCT01566461 - IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) | Biotech Hunter | Biotech Hunter