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

Abstract

BackgroundThe 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/designThis 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.DiscussionEffPac 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 registrationClinicalTrials.gov Identifier: NCT02540018, registered on 17 August 2015.Protocol version: CIP Version Final04, 11 February 2016.EUDAMED No: CIV-15-03-013204.

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial

“…The EffPac trial was a prospective, multicenter, participant- and core laboratory-blinded, randomized controlled study to compare Luminor® 35 DCB angioplasty with POBA in patients with femoropopliteal artery disease of Rutherford category 2–4. The detailed study design and eligibility criteria were published previously [ 1 , 10 ] (Supplementary Table 1). Patients of Rutherford category 2–4 and single femoropopliteal target lesions of ≤ 15 cm were enrolled at 11 German sites between September 2015 and December 2016.…”

“…Detailed description of the study intervention was provided earlier [ 1 , 10 , 12 ]. Briefly, patients were randomized only after the lesion had been crossed endoluminally with a guidewire and successfully pre-dilated with a standard balloon for 60 ± 10 s in both study arms.…”

“…Drug-coated balloon (DCB) angioplasty using the antiproliferative effect of paclitaxel has been shown to reduce late lumen loss (LLL) and prevent restenosis more successfully than plain old balloon angioplasty (POBA) [ 1 , 2 ]. However, effect size differs considerably across DCB types [ 3 ] and 5-year results are provided for only a few.…”

Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty

“…Detailed description of device and procedure, and the full study protocol had been provided earlier [22,23]. The EffPac trial is registered with ClinicalTrials.gov (NCT02540018).…”