EffPac Clinical Trial of iVascular's Luminor 35 DCB Begins Enrollment

October 8, 2015—The first two cases in the EffPac randomized, clinical, multicenter trial of iVascular’s Luminor 35 drug-coated balloon (DCB) system were successfully performed by Principal Investigator Prof. Ulf Teichgräber, MD, at Universitätsklinikum Jena in Germany, the company announced. iVascular, which is based in Barcelona, Spain, develops therapies and devices for the treatment of coronary and peripheral vascular diseases.

The Luminor 35 device incorporates a new coating technology based on the deposition of nanodrops of paclitaxel and a lipophilic ester on the surface of the balloon. The homogeneous, multilayer coating has shown promising efficacy in preclinical evaluations, according to the company.

In May 2015, iVascular announced the start of the EffPac clinical trial to evaluate safety and effectiveness of the Luminor 35 DCB system. The trial is designed to dilate stenotic or occlusive lesions (5 to 15 cm) in the superficial femoral artery and will enroll 172 patients with TASC II A and B lesions (Rutherford 2−4) in 11 sites in Germany; 86 patients will be treated with the Luminor 35 DCB and 86 patients will be treated with traditional balloon angioplasty.

The study’s primary endpoint is to evaluate the late lumen loss at 6 and 12 months. Secondary endpoints are target lesion revascularization and target vessel revascularization, as well as quality of life, amputation rate, mortality, improvement of Rutherford classification, ankle-brachial index, and walking distance at 6 and 12 months.

In the company’s press release, Prof. Teichgräber commented, “The main purpose of the EffPac trial is to confirm and broaden Luminor 35’s promising efficacy and safety results obtained in preclinical models. The results of the EffPac trial will allow direct comparison to other already completed randomized controlled trials applying paclitaxel-coated DCB in the same target vessel.”