Giannoni 2003.

Clinical features and settings	Participants scheduled to undergo endovascular repair of aortoiliac aneurysms. Type of stents received: not reported. Aneurysm diameter: not reported. Setting: department of vascular surgery.
Participants	30 consecutive participants; 29 men; mean age: 69 years; range: 50‐82 years. Comorbidities: not reported. Geography: Italy.
Study design	Cross‐sectional study.
Target condition and reference standard(s)	Target condition: endoleak. Definition of endoleak: endoleaks detected classified according to location of flow: type I at proximal or distal attachment sites, type II from patent lumbar or inferior mesenteric arteries, and type III at junction between graft and modular device extension. Endoleak (absolute n): 8. Prevalence of endoleak: 9.9% (8/81). Reference standard: CTA. Image acquisition: precontrast and contrast‐enhanced breath‐hold scans obtained in craniocaudal direction using: 3‐mm collimation, 4.5 mm/s table speed, 1.5:1 pitch ratio, 210 mA, 300 mm coverage, and 50 s exposure time (total of 62.5 rotations). Type of CT scanner: Somatom Plus‐S scanner (Siemens Medical Systems, Munich, Germany). Use of contrast: yes, used non‐ionic contrast agent (Omnipaque 300, Nycomed‐Amersham, Princeton, NJ, USA).
Index and comparator tests	Index test: CDUS. unenhanced US imaging; enhanced US imaging. Image production: "The aorta was examined with transverse and longitudinal B‐mode imaging from the renal to the distal iliac arteries; the maximal external diameter of the aneurysm sac in any direction was measured…To assess proper stent‐graft placement, the distance between the graft and the renal arteries and the diameter of the aortic neck were measured; colour flow sampling inside and outside the stent‐graft was used to verify graft patency and to detect endoleaks. A Doppler waveform analysis completed the investigation." Type of US: B‐mode, 3.5‐MHz probe (Acuson 128 XP 10; Acuson, Mountain View, CA, USA). Use of contrast: US enhancer was galactose‐based microbubble suspension 300 mg/mL (Levovist SHU508A, Schering AG, Germany). Operator: not reported.
Follow‐up	"On day 1 after the endovascular repair, unenhanced and enhanced ultrasound scans were performed. At 3 and 12 months and annually thereafter, aortic endograft surveillance included ultrasound (unenhanced and enhanced) imaging, CTA or MRA comparable to the preoperative study, and plain biplanar abdominal radiography, all performed within a 7‐day period."
Notes	26 bifurcated Vanguard stent‐grafts (Boston Scientific, Natick, MA, USA) deployed; 8 cases also had a straight Passeger extension (Boston Scientific) implanted; 2 straight Vanguard devices, 1 straight Passeger, and 1 straight Parodi style device. Other comparator tests used: MRA; plain abdominal radiography. Mean follow‐up: 30 months; range: 6‐60 months. Examinations performed at 3, 12, and 24 months.
Table of Methodological Quality
Item	Authors' judgement	Description
Representative spectrum? All tests	Yes	Consecutive series of participants referred for follow‐up to detect potential endoleaks.
Acceptable reference standard? All tests	Yes	Reference standard was CTA.
Acceptable delay between tests? All tests	Yes	All performed within 7‐day period.
Partial verification avoided? All tests	Yes	All study participants accounted for and results of reference standard reported for all.
Differential verification avoided? All tests	Yes	All participants who received index test subjected to same reference standard.
Incorporation avoided? All tests	Yes	Index test not part of reference standard.
Reference standard results blinded? All tests	Yes	2 experienced radiologists blinded to results of the US jointly assessed CTAs and MRAs.
Index test results blinded? All tests	Yes	Index test performed before reference standard.
Relevant clinical information? All tests	Yes	Clinical data available at time of test interpretation.
Uninterpretable results reported? All tests	Yes	All data were interpretable.
Withdrawals explained? All tests	Yes	"Endovascular AAA repair was technically successful in 27 (90%) patients. Two (6.7%) patients died in the periprocedural period: one after conversion to an open repair and the other after an additional intervention. Of the remaining 28 patients, 26 (93%) reached the 24‐month follow‐up (mean 30 months, range 6‐60). One patient died 6 months after the endovascular procedure of thoracic aortic dissection; a broken femur immobilized the other patient after he had completed the 12‐month evaluation. Complications during follow‐up included 2 (6.6%) limb occlusions at 6 and 12 months, 2 (6.6%) extension detachments at 6 and 24 months, 1 (3.3%) proximal detachment due to neck dilatation at 24 months, and 1 (3.3%) kinked stent‐graft that displayed wire breakage, necessitating late conversion to open repair. Other than the wire breakage, which was identified only at radiography, all major complications were detected by unenhanced ultrasound and by CTA/MRA."