Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry.

ABSTRACT:

Purpose:

To evaluate the safety and performance of the Treovance stent-graft.

Methods:

The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes.

Results:

Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-da

SUBMITTER: Uberoi R 

PROVIDER: S-EPMC6238168 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature