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The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial
Teichgräber et al. Trials
The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial
U. Teichgräber
R. Aschenbach
D. Scheinert
T. Zeller
K. Brechtel
M. Thieme
E. Blessing
M. Treitl
M. Lichtenberg
P. von Flowtow
B. Vogel
M. Werk
V. Riambau
A. Wienke
T. Lehmann
S. Sixt
Background: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. Methods/design: This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality. Discussion: EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel.
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Background
The Luminor® paclitaxel-coated drug-eluting balloon (DEB)
catheter (iVascular, S.L.U., Barcelona, Spain) is specially
designed for the percutaneous transluminal angioplasty
(PTA) technique. The DEB catheter is based on a
proprietary Transfertech® coating technology. This has
been engineered to improve clinical efficacy by optimizing
coating properties and device functionalities. It allows a
homogeneous and precise paclitaxel concentration of
3 μg/mm2 on the PTA balloon surface. This
patientblinded randomized controlled trial (RCT) focuses on
the efficacy and the clinical outcome of the Luminor®
paclitaxel-coated DEB catheter.
Experience in animal models has shown that
paclitaxelcoated DEB catheters demonstrate an inhibition of
neointimal hyperplasia after PTA [1]. The safety issue
of paclitaxel-coated DEB catheters has been well-investigated
in clinical studies for the use in femoropopliteal arteries using
paclitaxel-coated DEB catheters from other
manufacturers, with drug concentrations ranging from 2.0 to
3.5 μg/mm2 on the PTA balloon surface [2]. The
THUNDER and FemPac RCTs used the
iopromide-matrixcoated Paccocath® catheter with comparable study designs.
The results of both trials demonstrated that the
paclitaxelcoated DEB catheter offered superior restenosis inhibition
and reduced target lesion revascularization (TLR) rates in
the femoropopliteal artery [3, 4]. These results were
confirmed with IN.PACT Pacific® urea-matrix-paclitaxel-coated
DEB catheters in the same target vessel [5].
The EffPac study design follows the Trans-Atlantic
InterSociety Consensus – II (TASC II), which provides
comprehensive, evidence-based recommendations for vascular
practice and treatment decisions between
endovascular and surgical techniques. According to the TASC II
on femoropopliteal lesions, endovascular therapy is
the treatment of choice for type A lesions (single
occlusion ≤5 cm) and is the preferred treatment for type B
lesions (occlusions ≤15 cm) (Recommendation No. 37) [6].
The EffPac trial will include both TASC II type A and type
B lesions.
Study hypothesis
That Luminor® paclitaxel-coated balloon catheters will be
associated with significantly lower reocclusion and
restenosis rates as compared to noncoated, plain old
balloon angioplasty (POBA) catheters in both TASC II type A
and type B lesions (≤15 cm) of the superficial femoral artery
(SFA) and the proximal popliteal artery (PA).
Methods
Study design
EffPac is designed as a randomized controlled, multicenter
trial in which the Luminor® paclitaxel DEB catheter is
compared to the POBA catheter in de novo stenotic/restenotic
or occlusive lesions in the SFA and/or proximal PA to
prevent vessel restenosis or reocclusion (Fig. 1). The clinical
endpoints used for classification focus primarily on
effectiveness, followed by safety monitoring and side effects.
Study setting
The University Hospital Jena, as the coordinating study
center, is (...truncated)