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. 

Clinical data image ATK

Final Residual Stenosis

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Final Residual Stenosis

Bailout Stent Rate

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Bailout Stent Rate

FF CD-TLR/TVR at 6 months

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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)

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

– A. Holden, MBChB, FRANZCR, EBIR

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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

ATK 1

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%
ATK 2

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%
ATK 3

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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SERRATION TECHNOLOGY

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