Cordis has announced the start of the RADIANCY premarket clinical study in Europe.
A press release details that RADIANCY is a prospective, multicentre, single-arm study to assess the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system intended for treatment of lesions in the iliac, superficial femoral, or proximal popliteal arteries via radial artery access through 30-day follow up.
The first procedure was performed by Mercedes Guerra (University Hospital of Guadalajara, Guadalajara, Spain) using the Brite Tip Radianz guiding sheath and Saberx Radianz percutaneous transluminal angioplasty (PTA) balloon catheter to facilitate delivery of the S.M.A.R.T Radianz self-expanding stent in an iliac lesion.
Upon completion of the procedure, Guerra said: “My colleagues and I are pleased to have the opportunity to perform the first case in this significant clinical study. We applaud Cordis for pursuing the technological innovation to meet the need for radial access solutions in lower extremity interventions. We look forward to contributing our findings to the global endovascular community as part of the RADIANCY clinical study.”
The RADIANCY study, led by principal investigator Raphaël Coscas (Ambroise Paré Hospital, Boulogne-Billancourt, France), is planned to enrol 159 patients at approximately 15 sites across seven European countries. “The RADIANCY study initiation marks a new course for the future management of patients with peripheral arterial disease (PAD) by expanding their treatment options from current conventional femoral to radial access,” Coscas said.
Coscas also highlighted the era of practice evolution in this space: “As the gold-standard approach in coronary interventions, radial is in its exciting inception phase for PAD and offers unequivocal patient-centric advantages in terms of early mobility and comfort, critical in both in-patient and out-patient practice settings.”
The S.M.A.R.T. Radianz vascular stent system, specifically engineered for radial access, was approved by the US Food and Drug Administration (FDA) earlier this year, and successful first-in-human procedures were performed in June 2022 by Jihad Mustapha (Cardiac & Vascular Centers for Amputation Prevention, Grand Rapids, USA).
George Adams, Cordis chief medical officer, said: “Cordis is committed to developing tools to treat complex PAD patients. Understanding the real-world, 10-year S.M.A.R.T. vascular stent system data combined with the innovation of a radial approach allows the interventionalist to treat PAD safely, efficaciously, and cost effectively. Mirroring this innovation with research and a strong educational program to advance the field is truly at Cordis’ core.”