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 Oct 28;17(1):528. doi: 10.1186/s13063-016-1657-x.


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

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Angiography, Digital Subtraction
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Ankle Brachial Index
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Clinical Protocols
  • Coated Materials, Biocompatible*
  • Computed Tomography Angiography
  • Constriction, Pathologic
  • Exercise Tolerance
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Germany
  • Humans
  • Male
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Quality of Life
  • Recovery of Function
  • Recurrence
  • Research Design
  • Risk Factors
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Duplex
  • Vascular Access Devices*
  • Vascular Patency
  • Walking


  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Paclitaxel

Associated data