GREAT-a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results.

INTRODUCTION: Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial. METHODS: Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up. RESULTS: Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8). CONCLUSION: Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils. TRIAL REGISTRATION: http://www.germanctr.de , DRKS00003132.

GREAT-a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment.

The effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. GREAT is a randomized, controlled, multicentre trial in patients bearing cerebral aneurysms to be treated by coil embolization. Eligible patients were randomized to either coil embolization with HydroSoft/HydroFrame coils (>50 % of administered coil length), or bare platinum coils. Inclusion criteria were as follows: age 18-75, ruptured aneurysm (WFNS 1-3) and unruptured aneurysm with a diameter between 4 and 12 mm. Anatomy such that endovascular coil occlusion deemed possible and willingness of the neurointerventionalist to use either HydroSoft/HydroFrame or bare platinum coils. Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132).

C-arm cone beam computed tomography needle path overlay for image-guided procedures of the spine and pelvis.

INTRODUCTION: The aim of this study is to report our early clinical experience using C-arm cone beam computed tomography with fluoroscopic overlay for image guidance during percutaneous needle procedures of the spine and pelvis. METHODS: Twelve consecutive patients (four female and eight male patients; mean age, 64 years; range, 47-74 years; SD ± 7.6 years) who underwent percutaneous biopsy of the spine and pelvis for suspected metastasis (n = 12), spondylodiscitis (n = 6), abscess (n = 5) or bone tumour (n = 1) were prospectively included between March 2009 and November 2010. The procedures were performed on the Allura Xper FD20/20 (Philips, Best, the Netherlands) using cone beam computed tomography (XperCT) with the C-arm combined with fluoroscopic overlay for needle guidance. Based on an initial XperCT, entry and target points were defined using dedicated guidance software (XperGuide). The needle path was visualised in various reconstructed planes and could be adjusted when considered necessary. For percutaneous interventions, the entry view (overlay of entry and target point in the bull's eye fashion), the progression view (perpendicular to the entry view) as well as two additional views could automatically be piloted to with the C-arm system. Needle navigation was supported by a biopsy guidance device (Seestar, Radi, Uppsala, Sweden). Correct needle positioning was confirmed with a second XperCT acquisition. Technical success was defined as any target point reached via the planned needle trajectory with a distance of final needle tip within 5 mm of the planned target point in any direction. RESULTS: In all 12 patients, target areas could be defined based on XperCT data. In 11 of 12 (92%) cases, the target point was successfully reached on the planned trajectory with a mean error of 2.8 mm (range, 0.5-9.4 mm; SD, 2.4 mm). No peri- or post-interventional complications occurred. CONCLUSION: XperCT-guided interventions with the XperGuide system seem a safe and reliable tool for percutaneous needle interventions of the spine and pelvis. The advantage of the technique when compared to CT- or fluoroscopy-guided interventions needs to be determined in a comparative study of a larger scale.