iVascular presents the EffPac clinical trial for its drug coated balloon luminor 35

Thu 29th Jan – Dr. Sebastian Sixt presented the EffPac clinical trial to the audience in the Main Arena at LINC congress. The objective of this prospective study initiated by the University of Jena is to evaluate the safety and efficacy of the luminorpaclitaxel-eluting balloon in inhibiting restenosis and ensuring long‐term patency. The study will start next april 2015 and will include 172 patients to be enrolled in 9 centers in Germany:

  • Prof. U. Teichgräber, Universitätsklinikum Jena (Principal Investigator)
  • Prof. D. Scheinert, Universitätsklinikum Leipzig
  • Prof. T. Zeller, Herzzentrum Bad Krozingen
  • Dr. med. S. Sixt, Angiologikum GmbH
  • PD Dr. med. M. Treitl, Universitätsklinikum München
  • Prof. Dr. med. S. Duda, Ihre-Radiologen
  • Dr. med. M. Thieme, Medinos Kliniken Sonneberg
  • Prof. Dr. E. Blessing, SRH Karlsbad-Langensteinbach
  • PD Dr. H. Krankenberg, Herz,- und Gefäßzentrum Bad Bevensen

EffPac trial will be a 2-arm randomized study at 1:1 ratio between luminor 35 and POBA. Primary endpoint will be late lumen loss (LLL) defined as difference between artery diameter at 6-month follow-up minus post-procedure. Inclusion criteria will include peripheral vascular disease Rutherford class 2-4;de novo stenotic / re- stenotic lesions or occlusive lesions in the superficial femoral (SFA) and / or popliteal arteries (PA) with ≥70% diameter stenosis or occlusion; and target lesion length ≤15 cm (TASC II A and B).

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