LEVANT Japan.

Trial name or title	A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02‐LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Methods	Randomized controlled trial
Participants	Country: Japan Setting: single hospital Number of participants: 150 Inclusion criteria: Male or nonpregnant female ≥ 20 years of age Rutherford classification 2 to 4 Length ≤ 15 cm ≥ 70% stenosis Lesion location starts ≥ 1 cm below the common femoral bifurcation and terminates distally ≤ 2 cm below the tibial plateau and ≥ 1 cm above the origin of the tibioperoneal trunk A patent inflow artery as confirmed by angiography ≥ 1 patent native outflow artery to the ankle Exclusion criteria: Life expectancy of < 2 years History of hemorrhagic stroke within 3 months Previous or planned surgical or intervention procedure within 2 weeks before or within 30 days after the index procedure History of MI, thrombolysis, or angina within 2 weeks of enrolment Renal failure or chronic kidney disease Severe calcification that renders the lesion undilatable
Interventions	Uncoated balloon angioplasty device: unspecified DEB device: MD02‐LDCB balloon catheter Drug used: paclitaxel Vessels treated: femoropopliteal arteries
Outcomes	Primary: Composite of freedom from all‐cause perioperative (≤ 30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb reintervention, and index‐limb‐related death Secondary: Primary patency of the target lesion at 6 months. Primary patency is defined as the absence of target lesion restenosis (defined by Doppler ultrasound PSVR ≥ 2.5) and freedom from TLR
Starting date	March 2013
Contact information	Dr Osamu lida, Kansai Rosai Hospital Cardiovascular Internal Medicine
Notes	Sponsors: C.R. Bard and Medicon, Inc