CompletedNot Applicable

Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms

France492 participantsStarted 2021-03-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Presence of an abdominal aortic aneurysm greater than 50 mm in diameter, anatomically unsuitable for a standard infrarenal stent graft because of an inadequate infrarenal neck and for which a treatment by FEVAR or OR is considered. The AAA can be identified as follows, according to preoperative imaging:
✓. Patients aged 18 and over
✓. Patient who expressed a non-opposition to participating in the study.
✓. Patient affiliated to the French healyh care system

Exclusion criteria

✕. Presence of a type I, II, III or V thoracoabdominal aneurysm according to the modified Crawford Classification.
✕. Patients for whom an alternative surgical technique is being considered and listes below: laparoscopic aortic repair, hybrid repair, CHIMPS, surgeon modified stent grafting, in situ fenestrations.
✕. Patients deemed at prohibitive risk for OR :
✕. presence of a main renal artery less than 4 mm in diameter

What they're measuring

Incremental cost-utility ratio

Timeframe: at 36 months post-intervention

Trial details

NCT IDNCT04671732

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-14

View on ClinicalTrials.gov More Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open Repair trials