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

Trials, Oct 2016

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. Trial registration ClinicalTrials.gov Identifier: NCT02540018, registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

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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. - 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)


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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. 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, Trials, 2016, pp. 528, 17, DOI: 10.1186/s13063-016-1657-x