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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Holden, A; Hill, A; Walker, A; Buckley, B; Merrilees, S; Nowakowski, P; Krzanowski, M; Brodmann, M.
PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries.
J Endovasc Ther. 2019; 26(1):18-25
Doi: 10.1177/1526602818820787
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.
- Find related publications in this database (Keywords)
- angioplasty
- balloon catheter
- femoropopliteal segment
- scoring balloon
- serrations
- superficial femoral artery
- vessel preparation