Author + information
- Georgios Bouras1,
- Timothy Sullivan2,
- Thomas Zeller3,
- Masato Nakamura4,
- Ecaterina Cristea1,
- Zhao Xin1 and
- Alexandra Lansky1
Endovascular treatment of femoropopliteal artery (FPA) disease is challenging due to unique forces in this vascular segment, limiting stenting to designs that minimize focal deformation and providing longitudinal flexibility. The BioMimics 3D stent (Veryan, Horsham UK) is a self-expanding Nitinol stent with unique 3D helical centerline geometry to generate swirling blood flow. Pre-clinical studies and an earlier clinical study (Mimics) have indicated that the introduction of swirling blood flow reduces neointimal formation. This study is designed to demonstrate the safety and efficacy of the BioMimics 3D stent in the treatment of FPA disease.
This prospective, single arm, multicenter trial enrolled patients with symptomatic de novo obstructive or occlusive disease of the native FPA. An independent angiographic core laboratory reviewed all angiograms, and all events were adjudicated by independent committee. The primary safety endpoint is a composite of major adverse events (MAE) comprising death, any target limb major amputation or clinically-driven target lesion revascularization (TLR) at 30 days. Primary efficacy is stent patency at 12 months. We present procedural and in-hospital clinical outcomes.
271 subjects were enrolled, with a mean age of 68 years, 66% male, 81% smokers and 45% diabetics. Lesion length was 81.2 ± 38.4 mm and vessel diameter was 5.2 ± 0.9 mm; 46% had moderate to severe calcification and 30% were total occlusions. The baseline diameter stenosis (DS %) was 77.4% and final stent DS% was 11.5%. Lesion success (defined as successful stent implantation without device related complications) and procedure success (defined as lesion success without MAE) were 100%. There were no stent fractures, abrupt closure, spasm, distal embolization or perforation. Dissections > type C occurred in 1% of cases.
The unique design of the BioMimics 3D stent for treatment of FPA was safe and achieved excellent procedure success without procedural complications or stent fracture. Longer-term results will confirm whether these results are associated with sustained safety and efficacy.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention