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PRELUDE Study - ATK

Prospective, core-lab adjudicated

The Serranator® met its safety and efficacy endpoints in a preliminary study for the treatment of femoro-popliteal disease. There was 100% device technical success. The acute results of this feasibility study demonstrate that the Serranator® can safely achieve low residual stenosis. Successful lumen gain was achieved with an average post diameter stenosis of 23%, from a pre-procedure of 88%. In a majority of subjects (68%), the lumen gain was achieved with only 6 ATM of pressure. Serrations were documented by OCT or IVUS in all subjects (n=10) who underwent post Serranator imaging.

(NCT03001700) – https://journals.sagepub.com/doi/pdf/10.1177/1526602818820787

The initial outcomes demonstrate that the Serranator can achieve excellent lumen gain, with minimal dissection and low reintervention rates.

Final Residual Stenosis

Bailout Stent Rate

FF CD-TLR/TVR at 6 months

Serration Evidence

As part of the PRELUDE Studies, optical coherence tomography (OCT) and intravascular ultrasound (IVUS) were performed on a sub-set of cases. In all cases, imaging demonstrated serrations regardless of plaque morphology. (n=10/10 subjects)

OCT: “Shows clear evidence of serration caused by the Serranator® device.”

– A. Holden, MBChB, FRANZCR, EBIR

IVUS: “Controlled modification of severe intimal calcification by the Serranator®. Note the controlled acute luminal gain of the impacted calcified intimal layer.”

– J. Mustapha, MD