The PRELUDE Study
The PRELUDE Study (PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Popliteal Artery Using the Serranator DevicE) is a single-arm, prospective, multicenter feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The first case was performed in February 2017. The primary objectives are to collect safety and efficacy data, and to perform 30-day and 6-month follow-up. A secondary objective is to assess the feasibility of using OCT and/or IVUS in a subset of 10 patients to evaluate the presence of serrations. Dr. Andrew Holden (Auckland, New Zealand) is the Principal Investigator of the study, and the coinvestigators are Drs. Marianne Brodmann (Graz, Austria), Marek Krzanowski (Krakow, Poland), and Przemyslaw Nowakowski (Chrzanow, Poland).
The cases presented here are five of the subjects enrolled in the PRELUDE study to date. The SFA and popliteal lesions (Case 1, Case 2, and Case 3) ranged from mild to severe calcification. Each case demonstrates effective lumen gain with minimal injury and no flow-limiting dissections after the use of Serranator® Alto.
Angiography core lab adjudication was performed at Yale Cardiovascular Research Group under the direction of Alexandra Lansky, MD, and OCT/IVUS core lab adjudication was completed by University Hospitals, Harrington Heart and Vascular Institute under the direction of Hiram Bezzera, MD.
These early clinical results indicate that the effect of Serranator® Alto on atherosclerotic and calcified lesions, previously seen in preclinical bench, animal, and cadaver studies, is confirmed.
Enrollment in the PRELUDE study is ongoing. Six-month follow-up on all subjects is expected to be completed in Q4 2017.
CASE STUDY #4
IVUS of Serration Effect in Mid-SFA Lesion
Performed by Dr. Przemyslaw Nowakowski
Angiography by A. Lansky, MD, at Yale Cardiovascular Research Group. OCT/IVUS by H. Bezzera, MD, at University Hospitals, Harrington Heart and Vascular Institute.