Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) with stentplacement vs. standard PTA with stentplacement for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery (SFA). The RAPID trial.

Atherosclerotic lesions in the superficial femoral artery may cause
intermittent claudication and critical limb ischemia, leading to serious
complications such as tissue loss, amputation and even death. Revascularization
relieves symptoms and might prevent these complications. Over the last decade,
endovascular repair has become the preferred treatment for femoral arterial
obstructive disease. No definitive consensus has emerged concerning the best
endovascular strategy, for example if balloon angioplasty or stenting is
superior. However, literature is most supportive of balloon angioplasty with
stenting in longer segment lesions in the SFA. Paclitaxel covered balloons have
been found to reduce neo-intimal hyperplasia, and reduce restenosis. Recently,
the Legflow® Paclitaxel eluting balloon (Cardionovum Sp.z.o.o., Warsaw, Poland)
has been introduced. This Paclitaxel eluting balloon is covered with Shellac,
to obtain an equally distributed tissue concentration of Paclitaxel, reaching
an optimal dosis at a short inflation time of 45 seconds because of a high
delivery dose. This results in reduced neo-intimal growth, and reduces the risk
of local and systemic complications. In porcine models Paclitaxel/Shellac
coated balloons show a higher tissue concentration over time than other
Paclitaxel balloons, requiring a shorter inflation time for optimal tissue
concentrations. However, no randomized controlled trials have been performed on
this specific balloon in the superficial femoral artery. We hypothesize that
the Legflow PEB balloon in combination with Nitinol stents will lead to
significantly less hemodynamically significant restenosis when compared to
conventional uncovered balloons combined with Nitinol stents in treatment of
intermediate (>5 cm and < 15 cm) and long (> 15 cm) SFA lesions.
Hypothesis: The use of PDEB will reduce the restenosis rate of treated SFA
lesions compared to conventional PTA with stent.

The primary objective is to assess the difference in absence of binary
restenosis rate of endovascular treatment of intermediate and long lesions of
the superficial femoral artery with the Legflow® PEB and nitinol stent, when
compared to uncoated conventional balloon angioplasty and nitinol stent after a
2-year follow-up.
The secondary objectives are to asses the reocclusion rate, target-lesion
revascularization rate, clinical success, hemodynamic success, major amputation
rate, complication rate, mortality rate and cost-effectiveness of endovascular
treatment of intermediate and long lesions of the superficial femoral artery
with the Legflow® PEB and nitinol stents, when compared to conventional balloon
angioplasty and nitinol stent.

A randomized, controlled, patient-blind, multi-center trial.

The intervention group will undergo endovascular dilatation of intermediate and
long lesions of the SFA with the LegFlow® Paclitaxel eluting balloon followed
by placement of a nitinol selfexpandable stent (Supera®, IDEV inc., Webster
TX). The control group will undergo endovascular dilatation of the SFA with
standard PTA followed by placement of the same Supera® stent.

All devices, guidewires and catheters have CE-approval. Participating patients
will need to make five study-related hospital visits, which is standard for
this type of treatment. Five non-invasive duplex-ultrasound (DUS) studies and
five non-invasive ABI measurements with treadmill test will be performed, as
well as non-invasive toe pressure measurements (TcpO2). When compared to the
standard pre-procedural imaging and follow-up imaging, patients do not need to
make extra hospital visits. When treadmill test and DUS show possible
asymptomatic significant restenosis >75%, or symptomatic restenosis >50%
patients will receive additional digital subtraction angiography and
(re)intervention. This is routine in daily vascular practice. Furthermore,
patients will be asked to fill out a 13-item questionnaire at every follow-up
moment. The Shellac used on the catheter is recognized as safe by the FDA
(E904). Recently, the use of the DIOR 2 balloon (also covered with Shellac and
used in the cardiac field) for in-stent stenosis, and restenosis of small
cardiac vessels was safe at one year. TLR of the treated stenoses in this study
was 12%.