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,B Vogel,K Brechtel,R Aschenbach,M Werk,M Thieme,E Blessing,V Riambau,P Von Flowtow,T Lehmann,S Sixt,M Lichtenberg,M Treitl,A Wienke,D Scheinert,T Zeller

doi:10.1186/s13063-016-1657-x

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.

Highlights

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 in inhibiting restenosis and in ensuring long-term vascular patency
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 plain old balloon angioplasty (POBA) catheter for the superficial femoral artery (SFA) and the popliteal artery (PA)
The THUNDER and FemPac randomized controlled trial (RCT) 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]

Summary

Discussion

Multiple randomized “first-in-man” trials and registries [3, 4, 8, 9] of first-generation drug-coated balloon technology have convincingly demonstrated the superiority of paclitaxel-coated DEB angioplasty compared to POBA in relation to LLL, restenosis rate and freedom from TLR. The Stellarex® paclitaxel-coated DEB catheter (Spectranetics, Colorado Springs, CO, USA) was shown to be safe and effective with a lower paclitaxel concentration (2 μg/m2 paclitaxel) according to recent 24-month data released from the first in-man study (ILLUMINATE) [18] In this prospective, multicenter, single-arm study 58 femoropopliteal artery lesions in 50 patients were treated and the preliminary data revealed a primary patency rate of 80.3 % and freedom from clinically driven TLR of 85.8 % with no deaths or amputations at 24 months.

Background

Methods

Findings