PRELUDE BTK Study
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK Study
The PRELUDE BTK Study was a single-arm, multicenter, safety and feasibility study using the Serranator® PTA Serration Balloon Catheter in diseased infrapopliteal arteries.
PRELUDE BTK Study Highlights
The Serranator was found to be safe and effective in treating atherosclerotic disease of the infrapopliteal arteries. The PRELUDE BTK study also showed effective lumen gain with an average pre-procedure diameter stenosis of 81.3%, and an average post treatment diameter stenosis of 21.8%. The lumen gain was achieved using low atmospheric pressure (avg maximum of 6ATM). The mechanism of action was documented by OCT and IVUS. The Serration Angioplasty effect was shown in all 10 lesions imaged. A low re-intervention rate was observed. The Freedom from CD-TLR at 6-months was 97.7%.
For study details, please visit ClinicalTrials.gov
PRELUDE BTK Study Conclusions
- Serranator® is safe and effective in treating infrapopliteal artery lesions
- Acute results demonstrated a low residual stenosis (21.8%), low bailout stent rate (1.9%), and used low ATM pressure (6 ATM avg max) to achieve results
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All lesions imaged with OCT and IVUS showed serration
effect (n=10) - Low reintervention rate at 6-months, CD-TLR (97.7%)
- After 6 months 70% of subjects had an improvement in one or more Rutherford Clinical Categories
- No device related SAEs
Investigators
Andrew Holden, MBChB, FRANZCR, EBIR (PI)
Auckland, New Zealand
Michael Lichtenberg, MD (PI Europe)
Arnsberg, Germany
Marianne Brodmann, MD
Graz, Austria
Klaus Hertting, MD
Buchholz, Germany
Przemyslaw Nowakowski, MD
Chrzanów, Poland
Christian Wissgott, MD
Rendsburg, Germany


Case Examples
Tibial Peroneal
Trunk

- Stenosis: 100%
- Serranator® size: 3 x 40mm
- Maximum ATM: 6
- Post residual stenosis: 22%
- No dissection
Proximal & Distal Posterior Tibial

- Stenosis: 80%
- Serranator® size: 3 x 120mm
- Maximum ATM: 6
- Post residual stenosis: 22%
- No dissection
Distal Anterior Tibial

- Stenosis: 100%
- Serranator® size: 2.5 x 120mm
- Maximum ATM: 4
- Post residual stenosis: 15%
- No dissection
OCT & IVUS Show Serrations

IVUS: “Pre-intervention imaging showed diffuse circumferential superficial calcification (A-B). Post-Serranator imaging showed slits in the superficial calcium enabling enlargement of lumen without any dissection (A’-B’)” – Dr. Akiko Maehara
-Performed by Dr. Klaus Hertting

OCT Shows Serrations
– Performed by Dr. Andrew Holden