Author + information
- Peter Schneider1
This first-in-human study evaluates serration angioplasty on the arterial surface to enhance lumen gain and to promote constructive use of angioplasty force. The PRELUDE study assessed preliminary safety and efficacy of the Serranator® Alto PTA Serration Balloon Catheter in subjects with atherosclerotic disease of the superficial femoral and popliteal arteries.
Study design is a single arm, prospective, multi-center feasibility study. Acute angiographic data comparing the pre-Serranator® inflation versus post inflation effects were evaluated by an independent core lab. Inclusion criteria were claudication or ischemic rest pain, and de novo or non-stented re-stenotic lesions. Subjects with stenosis > 70%, lesion length < 10 cm, with reference vessel diameters of 4. 0 mm to 6. 0 mm inclusive, were included. Occlusions were allowed up to 6 cm in length. The primary safety endpoint was a composite of Major Adverse Events (MAE) plus Peri-procedural Death (POD) at 30 days post procedure. The primary efficacy endpoint was defined by device success with a final diameter stenosis < 50%. A secondary objective was to confirm the presence of serrations across the lesions using Optical Coherence Tomography (OCT) and or Intravascular Ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up after serration angioplasty is at 30 days and 6 months.
Twenty-five subjects enrolled at 4 study centers. Moderate or severe calcification was present in 56% (n=14) of subjects. Thirty-two percent of subjects (n=8) had chronic total occlusions. The average pre-treatment stenosis was 88% with a post treatment stenosis of 23%. Only 1 stent was placed (4%) post-Serranator®. There were no MAEs or POD reported. Serrations were confirmed by an independent core lab in all OCT or IVUS images (n=10).
This first-in-human study of serration angioplasty demonstrated safety and feasibility. Acute results suggest that the Serranator® can safely achieve low residual stenosis. The presence of serrations by OCT and IVUS in a wide variety of lesions demonstrates that serrations may play a role enhancing and improving the results of angioplasty. Final study results are pending, with 6-month follow up expected to be completed in 2017.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention