Clinical Evidence

PRELUDE Study - ATK

Clinical Outcomes

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

0

Final Residual Stenosis

0

Bailout Stent Rate

0

Freedom from CD-TLR at 6 months

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

Chart showing 87.6% to 22.7% reduction in diameter stenosis with Serranator treatment (NCT03001700 study data)

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 image showing serration evidence from Serranator device, per A. Holden MBChB FRANZCR EBIR

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

– A. Holden, MBChB, FRANZCR, EBIR

IVUS image showing controlled modification of calcified arterial layer with acute luminal gain from Serranator treatment

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

Angiographic sequence showing total occlusion of right proximal popliteal artery treated with Serranator, reducing stenosis from 100% to 20.23%

Right Proximal Popliteal with Total Occlusion

  • RVD: 4.19mm

  • Lesion length: 54.28mm

  • Stenosis: 100%

  • Serranator® size: 5 x 80mm

  • Inflation pressure: 6 ATM

  • Post-treatment residual stenosis: 20.23%

Angiographic sequence showing severely calcified right distal SFA lesion treated with Serranator, reducing stenosis from 94.59% to 24.07%

Right Distal SFA with Severe Calcification

  • RVD: 6.12mm

  • Lesion length: 30.04mm

  • Stenosis: 94.59%

  • Serranator® size: 6 x 40mm

  • Inflation pressure: 11 ATM

  • Post-treatment residual stenosis: 24.07%

Angiographic sequence showing left mid SFA lesion treated with Serranator, reducing stenosis from 77.02% to 12.84%

Left Mid SFA

  • RVD: 5.15mm

  • Lesion length: 28.42mm

  • Stenosis: 77.02%

  • Serranator® size: 5 x 40mm

  • Inflation pressure: 6 ATM

  • Post-treatment residual stenosis: 12.84%

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