Midterm results of proximal aneurysm sealing with the ovation stent-graft according to On-vs off-label use: Journal of Endovascular Therapy

riVascular Ovation Italian Study (TOIS) Collaborators

Research output: Contribution to journalArticlepeer-review

Abstract

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
Original languageEnglish
Pages (from-to)191-197
Number of pages7
JournalJournal of Endovascular Therapy
Volume24
Issue number2
DOIs
Publication statusPublished - 2017

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