Status:
COMPLETED
Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Complex Abdominal Aortic Aneurysm, ie. Juxtarenal or Suprarenal Aortic Aneurysms, Treated by Fenestrated Endovascular Aortic Aneurysm Repair or Open Repair
Eligibility:
All Genders
18+ years
Brief 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 i...
Eligibility Criteria
Inclusion
- 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:
- Short-neck or juxtarenal aneurysm: if treated by OR, would require an infrarenal proximal aortic suture, regardless of the level of clamping.
- Suprarenal aneurysm: if treated by OR, would require a suprarenal/supramesenteric/ supraceliac aortic cross clamping, and a proximal bevelled suture and/or a separate revascularization of at least one renal artery.
- Type IV thoracoabdominal aneurysm: aneurysm extending up to the level of the diaphragm pillars, requiring a supracoeliac clamping with a proximal bevelled suture and/or separate revascularization of at least one renal artery if treated by open surgery.
- 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
- 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 :
- uncompensated cardiac failure with LVEF \<40% (NYHA class III and IV)
- Coronary revascularization \< 1 month
- Large myocardial ischemia \>3 segments not revascularized or not revascularizable
- Non-revascularized or non-revascularizable unstable angina
- Non-operable tight aortic stenosis (mean gradient \> 40 mmHg, valve area \< 1 cm2, peak transvalvular velocity \> 4 m/s)
- Non operable significant mitral shrinkage (area \<1.5cm²)
- FEV1 \< 50% of the theoretical value
- Home oxygen therapy
- Chronic renal failure with clearance \< 30 ml/min
- presence of a main renal artery less than 4 mm in diameter
- Special anatomical configurations: horseshoe kidney, pelvic kidney.
- Lesions of "shaggy" aorta at the visceral segment or at the lower thoracic aorta
- History of abdominal aortic surgery (open or endovascular)
- Dissecting, infected, ruptured or painful aneurysm
- Life expectancy less than 2 years
- Person under judicial protection
- Person under tutorship or curatorship
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
March 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 14 2023
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT04671732
Start Date
March 14 2021
End Date
March 14 2023
Last Update
May 15 2023
Active Locations (1)
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1
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, Val De Marne, France, 94000