FINNPTX.
Trial name or title | Paclitaxel Eluting Stent in Long Superficial Femoral Artery Obstruction: a Prospective, Randomized Comparison With Bypass Surgery Using PTFE Graft in a Finnish Multicenter Study |
Methods | Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: treatment |
Participants | Individuals suffering from severe lifestyle limiting IC indicating revascularisation as well as individuals suffering from CLI and having de novo SFA obstruction with a total length ranging from 7 to 20 cm |
Interventions | Femoro‐popliteal artery bypass operation by using synthetic PTFE graft versus placement of paclitaxel‐eluting stent in long SFA obstruction |
Outcomes | Primary patency, amputation‐free survival |
Starting date | October 2011 |
Contact information | Hannu Manninen hannu.manninen@kuh.fi, Marja‐Liisa Sutinen marja‐liisa.sutinen@kuh.fi |
Notes | NCT0145722 Sponsors and Collaborators: Kuopio University Hospital; Helsinki University Central Hospital; Turku University Hospital; Tampere University Hospital; Oulu University Hospital; Finnish Society of Interventional Radiology; North Karelia Central Hospital; Paijat‐Hame Hospital District |