Abstract
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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Details
1 Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinikum Jena, Jena, Germany (GRID:grid.275559.9) (ISNI:0000 0000 8517 6224)
2 Abteilung für Interventionelle Angiologie, Universitätsklinikum Leipzig, Leipzig, Germany (GRID:grid.411339.d) (ISNI:0000 0000 8517 9062)
3 Herzzentrum Bad Krozingen, Bad Krozingen, Germany (GRID:grid.418466.9) (ISNI:0000 0004 0493 2307)
4 Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie, Berlin, Germany (GRID:grid.477348.b)
5 Medinos Kliniken Sonneberg Angiologie/Kardiologie/Diabetologie, Sonneberg, Germany (GRID:grid.477348.b)
6 SRH Klinikum Karlsbad-Langensteinbach, Karlsbad, Germany (GRID:grid.490718.3) (ISNI:0000000406368535)
7 Institut für Klinische Radiologie, Klinikum der Ludwig Maximilians Universität München – Campus Innenstadt, München, Germany (GRID:grid.5252.0) (ISNI:0000 0004 1936 973X)
8 Klinikum Arnsberg Angiologie, Arnsberg, Germany (GRID:grid.477417.6) (ISNI:0000 0004 0605 6830)
9 Westpfalz-Klinikum GmbH Standort II Kusel, Kusel, Germany (GRID:grid.477417.6)
10 Ruprecht-Karls-Universität Heidelberg, Analysezentrum III/Innere Medizin III, Heidelberg, Germany (GRID:grid.7700.0) (ISNI:0000 0001 2190 4373)
11 Martin-Luther-Krankenhausbetrieb GmbH, Berlin, Germany (GRID:grid.7700.0)
12 Hospital Clínic de Barcelona, Barcelona, Spain (GRID:grid.410458.c) (ISNI:0000 0000 9635 9413)
13 Martin-Luther-Universität Halle-Wittenberg, Institut für Medizinische Epidemiologie, Biometrie und Informatik, Halle (Saale), Germany (GRID:grid.9018.0) (ISNI:0000 0001 0679 2801)
14 Zentrum für Klinische Studien (ZKS), Universitätsklinikum Jena, Jena, Germany (GRID:grid.275559.9) (ISNI:0000 0000 8517 6224)
15 Angiologikum Hamburg, Hamburg, Germany (GRID:grid.275559.9)