CARDIONOVUM Announces Enrollment Completion of RAPID Trial

BONN – June 1, 2016 – CARDIONOVUM GmbH, a medical technology company developing and commercializing innovative medical devices such as drug-coated balloons and drug-eluting stents for the treatment of coronary and peripheral artery disease, today announced the completion of enrollment of the RAPID trial. Results will be used to further support the safety and effectiveness of CARDIONOVUM’s Legflow® drug-coated balloon (DCB).

The RAPID study is a multi-center, randomized, controlled, patient-blinded clinical trial comparing the Legflow® drug-coated balloon (DCB) and stenting to conventional percutaneous transluminal angioplasty (PTA) and stenting in 160 “real-world” patients with highly challenging intermediate and long lesions in the superficial femoral artery (SFA). Patients were pre-dilated according to randomization, and all patients were then treated with the Supera® peripheral stent system (Abbott Vascular). The primary endpoint is the absence of binary restenosis of the treated SFA segment at two years.

Preliminary adjudicated results for a subset of patients at 1 year presented at LINC 2016 showed very promising results in the Legflow group. These results are expected to be published in July.

Principal Investigator, Dr J.-P. de Vries from the St Antonius hospital in Nieuwegein, The Netherlands, said, “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.”

The study design for RAPID has been published in Trials 2013 14:87; DOI: 10.1186/1745-6215-14-87. 

Source: CARDIONOVUM GmbH