title: 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: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.
authors: Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747, Jena, Germany. ulf.teichgraeber@med.uni-jena.de.
authors: U
authors: U
authors: Teichgräber
authors: Universitätsklinikum Jena, Institut für Diagnostische und Interventionelle Radiologie, Am Klinikum 1, 07747, Jena, Germany.
authors: R
authors: R
authors: Aschenbach
authors: Universitätsklinikum Leipzig, Abteilung für Interventionelle Angiologie, Philipp-Rosenthal-Straße 27 C, 04103, Leipzig, Germany.
authors: D
authors: D
authors: Scheinert
authors: Herzzentrum Bad Krozingen, Südring 15, 79189, Bad Krozingen, Germany.
authors: T
authors: T
authors: Zeller
authors: Ihre-Radiologen Berlin Gemeinschaftspraxis für Radiologie, Budapester Straße 15-19, 13347, Berlin, Germany.
authors: K
authors: K
authors: Brechtel
authors: Medinos Kliniken Sonneberg Angiologie/Kardiologie/Diabetologie, Neustadter Str. 61, 96515, Sonneberg, Germany.
authors: M
authors: M
authors: Thieme
authors: SRH Klinikum Karlsbad-Langensteinbach, Guttmannstr. 1, 76307, Karlsbad, Germany.
authors: E
authors: E
authors: Blessing
authors: Klinikum der Ludwig Maximilians Universität München - Campus Innenstadt, Institut für Klinische Radiologie, Pettenkoferstraße 8a, 80336, München, Germany.
authors: M
authors: M
authors: Treitl
authors: Klinikum Arnsberg Angiologie, Stolte Ley 5, 59759, Arnsberg, Germany.
authors: M
authors: M
authors: Lichtenberg
authors: Westpfalz-Klinikum GmbH Standort II Kusel, Im Flur 1, 66869, Kusel, Germany.
authors: P
authors: P
authors: von  Flotow
authors: Ruprecht-Karls-Universität Heidelberg, Analysezentrum III/Innere Medizin III, Im Neuenheimer Feld 669, 69120, Heidelberg, Germany.
authors: B
authors: B
authors: Vogel
authors: Martin-Luther-Krankenhausbetrieb GmbH, Caspar-Theyß-Straße 27-31, 14193, Berlin, Germany.
authors: M
authors: M
authors: Werk
authors: Hospital Clínic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain.
authors: V
authors: V
authors: Riambau
authors: Martin-Luther-Universität Halle-Wittenberg, Institut für Medizinische Epidemiologie, Biometrie und Informatik, 06097, Halle (Saale), Germany.
authors: A
authors: A
authors: Wienke
authors: Universitätsklinikum Jena, Zentrum für Klinische Studien (ZKS), Postfach, 07740, Jena, Germany.
authors: T
authors: T
authors: Lehmann
authors: Angiologikum Hamburg, Wördemanns Weg 25-27, 22527, Hamburg, Germany.
authors: S
authors: S
authors: Sixt
mesh_terms: D015901:Angiography, Digital Subtraction; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible; D000072226:Computed Tomography Angiography; D003251:Constriction, Pathologic; D017079:Exercise Tolerance; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D005858:Germany; D006801:Humans; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D062666:Vascular Access Devices; D014654:Vascular Patency; D016138:Walking
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel