News | Drug-Eluting Balloons | June 03, 2016

Cardionovum Announces Enrollment Completion of RAPID Trial

Trial will compare treatment with Legflow drug-coated balloon and stenting to conventional percutaneous transluminal angioplasty and stenting

June 3, 2016 — Cardionovum GmbH recently announced the completion of enrollment of the RAPID trial. Results will be used to further support the safety and effectiveness of the company’s Legflow drug-coated balloon (DCB).

The RAPID study is a multi-center, randomized, controlled, patient-blinded clinical trial comparing the Legflow 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 one year presented at the Leipzig Interventional Course (LINC) 2016 showed very promising results in the Legflow group. These results are expected to be published in July.

Principal investigator J.-P. de Vries, M.D., 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.”

Legflow is a paclitaxel-coated peripheral balloon dilatation catheter indicated for the treatment of critical limb ischemia; de-novo and restenotic lesions of the superficial femoral artery (SFA), popliteal artery and below-the-knee (BTK) artery. The device delivers superior safety through the use of nanocrystalline paclitaxel particles of only 0.1μm in size, thus avoiding embolic or thrombotic effects and facilitating drug uptake in tissue. The SAFEPAX coating enables consistent and predictable drug delivery to the lesion site, resulting in homogenous and maximized drug absorption into surrounding arterial tissue.

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

Cardionovum’s products are not available for sale in the United States.

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