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
Final Residual Stenosis
Bailout Stent Rate
Bailout Stent Rate
FF CD-TLR/TVR at 6 months
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
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%
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%
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%
SERRATION TECHNOLOGY
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