Cardionovum has announced the completion of enrolment of the RAPID trial, which is investigating the safety and effectiveness of the company’s Legflow drug-coated balloon.
The RAPID study is a multicentre, randomised, controlled, patient-blinded clinical trial comparing the Legflow drug-coated balloon 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. Patients were pre-dilated according to randomisation, and all patients were then treated with the Super peripheral stent system (Abbott Vascular). The primary endpoint is the absence of binary restenosis of the treated superficial femoral artery segment at two years.
Preliminary adjudicated results for a subset of patients at one year presented at LINC 2016 showed very promising results in the Legflow group. These results are expected to be published in July, according to a company release.
Principal investigator, J-P de Vries from the St Antonius hospital in Nieuwegein, The Netherlands, says, “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 drug-coated balloon as an effective solution for the treatment of challenging superficial femoral artery lesions. We thank all the study collaborators for their support in recruiting patients.”