The first two cases in the EffPac randomised clinical multicentre trial of its luminor 35 drug-eluting balloon system have been successfully performed, according to iVascular.
Lluis Duocastella, CEO of iVascular, comments, “We have successfully implemented a new coating technology based on the deposition of nanodrops of paclitaxel and a lipophilic ester on the surface of a balloon. We are able to generate a homogeneous multilayer coating that showed promising efficacy outcomes in preclinical phase. Efficacy is optimised by enhancing coating mechanical endurance”.
The EffPac clinical trial, which began in May 2015, is designed to evaluate the safety and effectiveness of the CE marked luminor 35 drug-eluting balloon system, according to iVascular. The trial is designed to dilate stenotic or occlusive lesions (5–15cm length) in the superficial femoral artery, and will enroll 172 patients with TASC II A&B lesions (Rutherford 2-4) in 11 sites in Germany. Eighty-six patients will be treated with the luminor 35 DEB and 86 patients will be treated with plain-old balloon angioplasty (POBA).
The study’s primary endpoint is to evaluate the late lumen loss (LLL) at six and 12 months. Secondary endpoints are target lesion revascularisation (TLR) as well as target vessel revascularisation (TVR), quality of life, amputation rate, mortality, improvement of Rutherford classification, ankle-brachial index and walking distance at six and 12 months.
Principal investigator of the study, Ulf Teichgräber comments: “The main purpose of EffPac trial is to confirm and broaden luminor 35’s promising efficacy and safety results obtained in preclinical models. The results of EffPac trial will allow direct comparison to other already completed RCT applying paclitaxel coated DEB in the same target vessel”.
Clinical evidence from the study will be used to seek regulatory approvals required to register the luminor 35 DEB in countries worldwide. The luminor 35 DEB system is commercially available already as a CE marked product.