ZILVERPASS.

Trial name or title	The Cook ZILVER PTX Drug‐eluting Stent Versus ByPASS surgery of femoropopliteal TASC C & D lesions (ZILVERPASS)
Methods	Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Individuals presenting with lifestyle‐limiting claudication, rest pain, or minor tissue loss (Rutherford classification from 2 to 5)
Interventions	Zilver PTX paclitaxel‐eluting stent versus prosthetic bypass for TASC C and D femoro‐popliteal lesions
Outcomes	Primary outcome measures: primary patency at 12 months Secondary outcome measures: proportion of subjects who experience device malfunction or serious device‐related or serious adverse events within 30 days postprocedure Other outcome measures: technical success; infection rate/haematoma at puncture site or at incision sites requiring intervention; haemodynamic primary patency rate; primary assisted patency rate; secondary patency rate; target lesion revascularization; clinical success; serious adverse events
Starting date	August 2014
Contact information	Bavo Van Puyvelde ‐ Tel.: +32 52 25 28 22, email: office@fmrp.be
Notes	NCT01952457 Sponsors and Collaborators: Flanders Medical Research Program

CLI: critical limb ischaemia
 IC: intermittent claudication
 NIHR: National Institute for Health Research
 PAD: peripheral arterial disease
 PTFE: polytetrafluoroethylene
 QoL: quality of life
 SFA: superficial femoral artery
 TASC: Trans‐Atlantic Inter‐Society Consensus Document on Management of Peripheral Arterial Disease