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.  

Publication: Holden A, Lichtenberg M, Nowakowski P, Wissgott C, Hertting K, Brodmann M. Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study. Journal of Endovascular Therapy. November 2021.

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
  • 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