Enrollment Completed in RAPID Trial of Cardionovum's Legflow DCB in SFA

June 1, 2016—Cardionovum GmbH has announced the completion of enrollment in its RAPID trial, which is evaluating the safety and effectiveness of the Legflow drug-coated balloon (DCB). Legflow is a paclitaxel-coated peripheral balloon dilatation catheter designed for the treatment of critical limb ischemia as well as de novo and restenotic lesions of the superficial femoral (SFA), popliteal, and below-the-knee arteries.

According to Cardionovum, the multicenter, randomized, controlled, patient-blinded clinical trial is comparing the Legflow DCB and stenting to conventional percutaneous transluminal angioplasty and stenting in 160 real-world patients with highly challenging intermediate and long lesions in the SFA. RAPID’s primary endpoint is the absence of binary restenosis of the treated SFA segment at 2 years. Patients in the study were predilated according to randomization, and all patients were then treated with the Supera peripheral stent system (Abbott Vascular).

The company noted that preliminary adjudicated results for a subset of patients at 1 year indicated promising results in the Legflow group. The data were presented in January at LINC 2016, the Leipzig Interventional Course in Leipzig, Germany, and are expected to be published in July.

In Cardionovum’s press release, RAPID Principal Investigator Jean-Paul de Vries, MD, commented, “We look forward to seeing the final results of the RAPID trial, which we expect will confirm the promising results we have seen so far. These results are expected to validate the Legflow DCB as an effective solution for the treatment of challenging SFA lesions. We thank all the study collaborators for their support in recruiting patients.” Dr. de Vries is Head of the Department of Vascular Surgery from St. Antonius Hospital in Nieuwegein, The Netherlands.