Author + information
- Armando Tellez1,
- Krista N. Dillon1,
- Dane A. Brady1,
- Luciano Curado2,
- Alexander Moreira3 and
- Serge Rousselle1
Covered stents are widely used to address numerous areas of need in peripheral intervention.However, PTFE covered stents have a known relative inflexibility which makes deliverability difficult and associated with a high restenosis rate. In this study we aim to evaluate the performance and vascular response of a new peripheral covered stent in a large animal model as compared to a commercially available PTFE covered stent.
Six swine were enrolled(45±1 kg). Superficial femoral arteries recieved Solaris (Scitech, Sao Paulo, Brazil) or Fluency (Bard, Tempe, AZ). Stents utilized were 40 mm long for both groups and implanted aiming for a 1.1:1 ratio. Following implantation, animals were recovered and followed for 30 days. At 30 day post-implantation all stents were evaluated under optical coherence tomography (OCT), explanted and subjected to stent integrity analysis and histopathological evaluation.
11 stents were evaluated (Solaris n=6, Fluency n=5). The operator described the Solaris stent as demonstrating a higher navigability when compared to the Fluency stent. The hydrophilic coated delivery system of the Solaris stent allowed a smoother release of the device without any sudden “jump” and greater geographical precision at implantation. At 30 days, OCT revealed a similar stent area for both groups (Solaris 25.8±4.7 vs Fluency 24.7±5mm2). However, Solaris demonstrated a higher lumen area (Solaris 18±4.2mm vs Fluency 13.9±3.4mm2) with a lower neointimal area (Solaris 7.8±1.8 vs Fluency 10.8±2.4mm2) compared to control. This led to a higher percentage stenosis in the control group (Solaris 31.9±7 vs Fluency 44.8±6%). The integrity analysis of the stents via radiographs revealed no fractures in any stent from either group. The results of the histopathological evaluation will be presented in the meeting.
The Solaris PTFE-covered peripheral stent demonstrated a resistance to fracture with increased flexibility and navigability and better conformability to artery curvature. The release system allowed for an accurate geographical delivery and the components of the device produced a lower OCT morphometrically-assessed neointimal response when compared to the control group.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention