NCT01183117.

Trial name or title	A clinical investigation of SM‐01 stenting versus PTA for the treatment of superficial femoral artery disease
Methods	Randomised controlled trial
Participants	Men or women 20 years or older. Inclusion criteria: Symptomatic leg ischaemia by Rutherford Classification (category 1, 2, or 3). Lesion length ≥ 40 mm to ≤ 150 mm (must be treatable with no more than 2 SM‐01 stents. Overlap should be about 1 cm if 2 stents are used) Reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 7.0 mm. All lesions are to be located ≥ 3.0 cm proximal to the superior edge of the patella, and ≥ 1.0 cm distal to the SFA/PFA bifurcation. ≥ 50% stenosis or total occlusion. Patent infrapopliteal and popliteal arteries, i.e., single‐vessel runoff or better with at least 1 of 3 vessels patent (< 50% stenosis) to the ankle or foot.
Interventions	Device: SM‐01 SM‐01 is a self‐expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 ‐ 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery. Active comparator: PTA balloon angioplasty.
Outcomes	Primary outcome measures: Non‐TVF (Target vessel failure) rate (time frame: 12 months). The primary endpoint will be freedom from TVF defined as any events of clinical driven (confirmed by duplex ultrasound or angiography) TLR/TVR, procedure failure, amputation of the target lesion's leg, procedure‐ or device‐related death, occlusion of target lesion, or > 70% restenosis of target lesion.
Starting date	July 2010
Contact information	Takuro Takagi, MD
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