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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medtronic Endovascular · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).

Conditions

• Femoral Artery Stenosis
• Popliteal Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Artery Occlusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-09-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2013-09-20
• Last updated: 2019-01-31

Locations

1 site across 1 country: Japan