Cagent Vascular has announced the completion of enrolment in the first-in-human PRELUDE study. The purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the company’s Serranator Alto device used in the superficial femoral artery (SFA) and/or popliteal artery.
The PRELUDE study is led by principal investigator, Andrew Holden (Auckland, New Zealand). Other investigators participating in this study are Marianne Brodmann (Graz, Austria), Marek Krzanowski (Kraków, Poland) and Przemyslaw Nowakowski (Chrzanów, Poland). The centres enrolled 25 subjects and will participate in a 30-day and six-month follow-up.
“The PRELUDE trial evaluating the first in human experience of the Serranator device has rapidly completed enrolment. Excellent acute results were achieved with 100% device success and a very low bail out stent rate despite a significant number of lesions containing chronic total occlusions and severe calcification. Interestingly, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) confirmed serrations were visible in all imaged patients. We look forward to following these patients as the trial progress,” says Holden.
The Serranator Alto device has four external metal serrated strips embedded on a semi-compliant balloon and is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion. The device received US Food and Drug Administration (FDA) 510(k) clearance earlier this year. The Serranator Alto percutaneous transluminal angioplasty serration balloon catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, and popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. (Not for use in the coronary or neuro-vasculature.)
Cagent Vascualr co-founder, Peter Schneider, comments, “We are impressed with these acute results which showed a reliable increase in lumen gain and arterial expansion.”
“Our next addition to our family of products will be for below-the-knee treatment with the Serranator Bass, currently in development,” states Carol A Burns, president and chief executive officer of the company.