TY - JOUR
T1 - Midterm results of proximal aneurysm sealing with the ovation stent-graft according to On-vs off-label use
T2 - Journal of Endovascular Therapy
AU - De Donato, Gianmarco
AU - Setacci, F
AU - Bresadola, L
AU - Castelli, Patrizio
AU - Chiesa, R
AU - Mangialardi, N
AU - Nano, G
AU - Setacci, C
AU - riVascular Ovation Italian Study (TOIS) Collaborators
N1 - Kahlberg, A in appendice
PY - 2017
Y1 - 2017
N2 - Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks 2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was-0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length
AB - Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks 2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was-0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length
U2 - 10.1177/1526602816685581
DO - 10.1177/1526602816685581
M3 - Article
VL - 24
SP - 191
EP - 197
JO - Journal of Endovascular Therapy
JF - Journal of Endovascular Therapy
SN - 1526-6028
IS - 2
ER -