PRELUDE Enrollment Completed for Cagent Vascular's Serranator Alto PTA Device
June 5, 2017—Cagent Vascular announced the completion of enrollment in the first-in-human PRELUDE study of the company's Serranator Alto percutaneous transluminal angioplasty (PTA) serration balloon catheter, which has received US Food and Drug Administration (FDA) 510(k) clearance. The study investigators have enrolled 25 patients and will conduct 30-day and 6-month follow-up.
PRELUDE is a prospective, single-arm, multicenter feasibility study that aims to show the safety and efficacy of the Serranator Alto device used in the superficial femoral artery and/or popliteal artery.
The PRELUDE study is led by Principal Investigator Andrew Holden, MD, from Auckland, New Zealand. Other investigators participating in this study are Marianne Brodmann, MD, from Graz, Austria; Marek Krzanowski, MD, from Kraków, Poland; and Przemyslaw Nowakowski, MD, from Chrzanów, Poland.
In the company's announcement, Dr. Holden commented, “The PRELUDE trial evaluating the first-in-human experience of the Serranator device has rapidly completed enrollment. Excellent acute results were achieved with 100% device success and a very low bailout stent rate, despite a significant number of lesions containing chronic total occlusions and severe calcification." He added, "Interestingly, intravascular ultrasound and optimal coherence tomography confirmed serrations were visible in all imaged patients. We look forward to following these patients as the trial progress."
The Serranator Alto device is composed of four external metal serrated strips embedded on a semicompliant balloon and is designed to create multiple longitudinal lines of interrupted microserrations to aid arterial expansion.
In February, Cagent Vascular announced FDA clearance for the Serranator Alto PTA serration balloon catheter for the treatment of peripheral artery disease. Serranator Alto is indicated for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulas. The device is not for use in the coronary or neurovasculature, advised the company.