Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, Val De Marne, 94000, France
NCT Number: NCT04671732
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. These CAAA are usually treated either by fenestrated endovascular aortic repair (FEVAR) or open repair (OR). Data comparing these thechniques remain scarce, mainly consisting of systematic reviews based on retrospective studies. Although mid-term and long-term results remain uncertain, FEVAR has gained widespread acceptance in the vascular community. However, this practice is not evidence base. Beyond clinical results, whether FEVAR is cost-effective or not is not demonstrated. A randomized controlled trial comparing FEVAR and OR is unlikely to be conducted since centers have developed specific expertise and practice, and most of surgeons are not keen to randomize patients. Thus, we believe that a prospective comparative multicentric cohort, with a propensity score and minimization of selection, classification and confusion bias is the most realistic way to provide reliable comparative data on cost effectiveness of FEVAR and OR. Overall, 382 patients are expected to be included (159 in each group).
Objective: The objective of this prospective non-randomized comparative multicenter cohort study is to compare the cost effectiveness incremental ratio at 36 months of FEVAR and OR for CAAA.
Method: Patients with CAAA discussed for FEVAR or OR in 37 french vascular centers in during a two years inclusion period constitute the population study. Preoperative and postoperative clinical and imaging data will are collected prospectively in eCRF forms. QOL before and after treatment is assessed by the E5D5L. The follow-up period is three years. The primary outcome is the Incremental cost-utility ratio (cost/QALY) at 36 months. We plan to minimize indication biases by using a proposensity score (proposnsity score maching and Inverse probablility of treatment weighting) based on clinical and anatomic characteristics. Patient at prohibitive risk for OR are excluded. Patient anatomically unsuitable for FEVAR are also excluded .
Conclusion: This study should provided valuable data on cost effectiveness of FEVAR for CAAA. Sub-goup analysis will be also conducted.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Créteil, Val De Marne, 94000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fenestrated endovascular aortic aneurysm repair consists in excluding a juxtrenal or suprarenal aneurysm by deploying a covered stent (stent graft) in the aorta so as to created sealing zones on both sides of the aneurysm. Since the proximal sealing is located in the visceral segment of the aorta, fenestrations are created to maintain blod flow in renal and visceral arteries. These fenestrations are custom made for each patient. Brindging covered stents are deployed between each fenestration and corresponding target arteries in order to insure sealing of the system.
Open repair of abdominal aortic aneurysms consists in cross-clamping the aorta on both sides of the aneurysm and replace the diseased segment by a prosthetic graft.
Time frame: at 36 months post-intervention
cost-effectiveness ratio of fenestrated endovascular aortic aneurysm repair (FEVAR) versus Open repair (OR) in the management of complex AAA in real life
Time frame: at 30 days
Comparison of quality of life after FEVAR and OR Quality of life 1 month after surgery,as assessed by EQ5D3L questionnaire
Time frame: at 36 months)
Comparison of quality of life after aortic aneurysm repair or open repair Quality of life 36 months after surgery as assessed by EQ5D3L questionnaire
Time frame: at 36 months
Comparison of overall and aortic-related mortality rates after aortic aneurysm repair or open repair
Time frame: at 30 days
Percentage of deaths after surgery
Time frame: at 36 months
Comparison of complication rates after aortic aneurysm repair or open repair
Time frame: at 1 month
Comparison of complication rates after aortic aneurysm repair or open repair
Time frame: at 1 month
Comparison of reintervention rates after 1 month FEVAR and OR surgery
Time frame: at 36 month
Comparison of reintervention rates after 36 month aortic aneurysm repair or open repair
Assistance Publique - Hôpitaux de Paris
Other
Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms: a Prospective Multicenter Comparative Cohort Study
Acronym: ORFEVAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00488943
Abdominal Aortic Aneurysm, Aneurysm
San Francisco, California, United States
View Trial DetailsNCT02996396
Abdominal Aortic Aneurysm, Aneurysm
Augsburg, Germany
View Trial DetailsNCT07581392
Aneurysm, Aneurysm Abdominal
Limerick, Munster, Ireland
View Trial DetailsNCT02894749
Aneurysm, Aortic Aneurysm
Lille, France
View Trial Details