Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg, Free and Hanseatic City of Hamburg, Germany
Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)
Binary restenosis rate by Duplex-ultrasound \>= 50% measured as proximal peak velocity ratio PVR\[prox\] \>= 2.4
Time frame: 6 month
Recurrent restenosis within the stent at 12 month
Recurrent restenosis \>= 50% measured as proximal peak velocity ratio PVR\[prox\] \>= 2.4
Time frame: 12 month
Clinically driven target lesion revascularization (TLR) at 6 and 12 month
Time frame: 6 and 12 month
Recurrent stenosis >= 70% within the stent at 6 and 12 month
Recurrent restenosis \>= 70% measured as proximal peak velocity ratio PVR\[prox\] \>= 3.4
Time frame: 6 and 12 month
Clinical and hemodynamic parameters
Walking distance, ABI, Rutherford category
Time frame: at 1, 6 and 12 month
Primary angiographic success rate
Angiographic sucess: \<50% residual stenosis
Time frame: 12 month
Major adverse vascular events (MAVE)
Time frame: 12 month
Death
Time frame: 12 month
Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points
Time frame: 6 and 12 month
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