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) was a single-arm, prospective, multicenter feasibility study that enrolled 25 subjects with superficial femoral or popliteal lesions.
For study details, please visit ClinicalTrials.gov
PRELUDE Conclusions
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
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- Left Mid SFA
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 Serration Effect
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
Clinical Data
Preliminary study data indicates that the Serranator® Alto is safe and effective in treating femoro-popliteal disease. There was 100% device technical success. The acute results of this feasibility study demonstrate that the Serranator® Alto 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.
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