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

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@article{ac070a5e8ca74ad5aeff3da9d8cbcad2,
title = "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-day mortality and 1{\%} major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96{\%}) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4{\%}) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6{\%} (95{\%} CI 91.4{\%} to 97.8{\%}). Other estimates were 95.5{\%} (95{\%} CI 91.7{\%} to 97.6{\%}) for freedom from endoleak type I/III and 97.4{\%} (95{\%} CI 94.2{\%} to 98.9{\%}) for freedom from aneurysm expansion. Thirteen (6.4{\%}) patients died; no death was aneurysm related.CONCLUSION:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.",
author = "Raman Uberoi and Carlo Setacci and Mario Lescan and Antonio Lorido and David Murray and Zolt{\'a}n Szeberin and Tomasz Zubilewicz and Vincent Riambau and Angsu Chartrungsan and J{\"o}rg Tessarek and Lars L{\"o}nn and {RATIONALE Investigators (Lars L{\"o}nn, members)}",
year = "2018",
month = "12",
doi = "10.1177/1526602818803939",
language = "English",
volume = "25",
pages = "726--734",
journal = "Journal of Endovascular Therapy",
issn = "1526-6028",
publisher = "Alliance Communications Group",
number = "6",

}

RIS

TY - JOUR

T1 - Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair

T2 - One-Year Results From the RATIONALE Registry

AU - Uberoi, Raman

AU - Setacci, Carlo

AU - Lescan, Mario

AU - Lorido, Antonio

AU - Murray, David

AU - Szeberin, Zoltán

AU - Zubilewicz, Tomasz

AU - Riambau, Vincent

AU - Chartrungsan, Angsu

AU - Tessarek, Jörg

AU - RATIONALE Investigators (Lars Lönn, members)

A2 - Lönn, Lars

PY - 2018/12

Y1 - 2018/12

N2 - 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-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related.CONCLUSION:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

AB - 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-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related.CONCLUSION:: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

U2 - 10.1177/1526602818803939

DO - 10.1177/1526602818803939

M3 - Journal article

VL - 25

SP - 726

EP - 734

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

SN - 1526-6028

IS - 6

ER -

ID: 55695420