EffPac Trial Evaluates iVascular's Luminor DCB at 12 Months

May 1, 2018—iVascular recently announced that 12-month results from the full clinical cohort of the EffPac randomized controlled trial studying the company's Luminor drug-coated balloon (DCB) were presented at the Charing Cross International Symposium, held April 24–27 in London, United Kingdom. The main objective of the EffPac trial was to assess the effectiveness of the Luminor DCB versus plain old balloon angioplasty (POBA) with an uncoated balloon catheter in the superficial femoral and popliteal arteries.

According to the company, the 12-month outcomes, which demonstrated high statistical significance for the Luminor DCB versus POBA, confirmed and maintained the 6-month outcomes that were presented at LINC 2018, the Leipzig Interventional Course, held January 30 to February 2 in Leipzig, Germany.

The study's primary endpoint was late lumen loss at 6 months, which was 0.14 mm in the Luminor DCB group versus 1.06 mm in the POBA group (P < .001).

At 12 months, the target lesion revascularization rates were 1.3% in the Luminor DCB group versus 17.7% in the POBA group (P < .001). Primary patency was 90.3% in the Luminor DCB group versus 65.3% in the POBA group (P < .001). Also at 12 months, Rutherford class improvement was 90.6% in the Luminor group (P = .006).

The paclitaxel-coated Luminor device features the company's Transfertech, which applies a uniform dosage of the drug by ultrasonic depositions of uniform diameter nanodrops, thereby minimizing drug loss during navigation and enhancing delivery to the artery wall, stated iVascular.

In the company's announcement, EffPac Principal Investigator Professor Ulf Teichgräber, MD, commented, "What is so special about Luminor DCB, is its unique nanocoating technology, which is ultra-thin and uniform.” He added, “Luminor provides the best DCB outcomes, according to comparison of EffPac with trials of similar design.”