Primary Outcome Measures:
- In-Segment Binary Restenosis [ Time Frame: 12-months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean percent diameter stenosis (%DS) and minimal lumen diameter (MLD) measured by quantitative angiography post-procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- In-segment late loss measured by quantitative angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- In-stent late loss measured by quantitative angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Patency defined as detectable flow measured by Duplex Ultrasound. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
- Target Lesion Revascularization (TLR), and Target Vessel Revascularization (TVR). [ Time Frame: 6 weeks, 6 and 12 months; ] [ Designated as safety issue: Yes ]
- Assessment for stent fractures by X-Ray. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Device Success defined as achievement of a final residual diameter stenosis of <30% (by QA), using the assigned device only. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- Lesion Success defined as achievement of <50% (by QA) residual stenosis using any percutaneous method. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- Procedural Success defined as achievement of final diameter stenosis of <50% (by QA) using any percutaneous method, without the occurrence of an SAE up to catheter sheath removal or subject leaving the cath lab, whichever is earlier. [ Time Frame: post procedure ] [ Designated as safety issue: No ]
- Procedural Complications defined as any adverse event from the time of arterial punction up to the moment of catheter sheath removal or subject leaving the cath lab, whichever is earlier. [ Time Frame: post procedure ] [ Designated as safety issue: Yes ]
- Serious Adverse Events at procedure up to discharge. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: Yes ]
- Rutherford classification at screening. [ Time Frame: 6 weeks, 6 and 12 months; ] [ Designated as safety issue: No ]
- Ankle Brachial Index measured at screening. [ Time Frame: 6 weeks, 6 and 12 months; ] [ Designated as safety issue: No ]
- Amputation. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
- Quality of Life assessment. [ Time Frame: 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
- Wound status of index limb (if applicable) due to CLI measured by digital photography, depth/length/width measurements, infection and wound closure status. [ Time Frame: screening, 6 weeks, 6 and 12 months ] [ Designated as safety issue: No ]
This is a multicenter, prospective, randomized study to be conducted in 17 centers in Europe. A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4, or 5).
All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months.