Clinical Data

PRELUDE Study Summary

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.

For study details, please visit ClinicalTrials.gov

PRELUDE Conclusions

Serranator Alto is safe and effective in treating critical femoro-popliteal lesions
100% technical success
Confirmation of serration effect by OCT and IVUS
Acute results show that Serranator Alto can achieve low residual stenosis
Serranator Alto showed effectiveness in moderate to severe calcification
Majority of subjects successfully treated at low pressure inflation
Final study results by the close of 2017

Investigators

Andrew Holden, MBChB, FRANZCR, EBIR (PI)
Auckland, New Zealand

Marianne Brodmann, MD
Graz, Austria

Marek Krzanowski, MD
Kraków, Poland

Przemyslaw Nowakowski, MD
Chrzanów, Poland

Case Examples

Right Proximal Popliteal with Total Occlusion

Right Distal SFA with Severe Calcification

The reference vessel diameter was 4.19 mm; lesion length was 54.28 mm; percent stenosis was 100% (A). A 5 mm X 80 mm Serranator® Alto was inflated to 6 atm (B). After treatment, residual stenosis was 20.23% (C).

The reference vessel diameter was 6.12 mm; lesion length was 30.04 mm; percent stenosis was 94.59% (A). A 6 mm X 40 mm Serranator® Alto was inflated to 11 atm (B). After treatment, residual stenosis was 24.07% (C).

The reference vessel diameter was 5.15 mm; lesion length was 28.42 mm; percent stenosis was 77.02% (A). A 5 mm X 40 mm Serranator® Alto was inflated to 6 atm (B). After treatment, residual stenosis was 12.84% (C).

PRELUDE Study OCT & IVUS Images Show Serrations

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

– J. Mustapha, MD

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

– A. Holden, MBChB, FRANZCR, EBIR

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