Trials | GREAT 2018 (DRKS00003132) | PRET 2017 (NCT00626912) | Poncyljusz’s RCT 2014 (EURR-6928) | HELP 2011 (ISRCTN30531382) |
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Regions | 22 centers in 2 countries | 25 centers in 6 countries | 1 centers in 1 country | 24 centers in 7 countries |
Publication | Stroke | Am J Neuroradiol | European Journal of Radiology | Lancet |
Inclusion Criteria | Ruptured or unruptured IAs; WFNS grade: 0–3; Age: 18–75 years; IA size: 4-12 mm in diameter; Endovascular occlusion is deemed possible; Neurointerventionist is content to use either HC or BPC. | Ruptured or unruptured IAs; WFNS grade: 0–3; Age: > 18 years; Life expectancy: > 2 years Endovascular occlusion is considered possible by both coils; Neurointerventionist is satisfied with using either HC or BPC but not other type. | Only unruptured IAs; Endovascular occlusion is considered possible by both coils; Neurointerventionist is satisfied with using either HC or BPC but not other type. | Ruptured or unruptured IAs; Previously untreated IAs; Not pregnant; WFNS grade: 0–3; Age: 18–75 years; IA size: 2-25 mm in maximum diameter; Endovascular occlusion is deemed possible; Neurointerventionist is content to use either HC or BPC. |
Exclusion Criteria | Patients already randomized in this trials; Pre-treated IA by coiling or clipping; More than one IAs need to be treated at the same treatment episode. | Other IAs requiring to be treated at the same treatment episode; Presence of AVM; Absolue contraindication to endovascular treatment. | Ruptured IAs; Intolerance to heparin or resistance to antiplatelet therapy, coagulopathies and abnormal platelet outcome. | Patients already randomized in this trials; More than one IAs need to be treated at the same treatment episode. |
Study Design | Second-generation hydrogel coil (HydroSoft and/or HydroFrame) vs. Bare platinum coil | First or Second-generation hydrogel coil vs. Bare platinum coil | Hydrogel-coated coil vs. Bare platinum coil | First-generation hydrogel coil vs. Bare platinum coil |
Efficacy outcomes | Complete occlusion, residual neck and residual aneurysm at periprecedure and 6–18 months; Recurrence, retreatment and mRS responese at 6–18 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure; Recurrence, retreatment and mRS responese at 18 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure and 12 months; Recurrence, retreatment and mRS responese at 12 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure and 18 months; Recurrence, retreatment and mRS responese at 18 months. |
Safety outcomes | Thromboembolic complications, coil migration, peforation, etc. at periprecedure; AEs, SAEs and death at periprocedure and 6-18 months. | Thromboembolic complications, hydrocephalus, peforation, etc. at periprecedure; AEs, SAEs and death at periprocedure and 18 months. | Thromboembolic complications, hydrocephalus, cerebral edema, etc. at periprecedure; AEs and death at periprocedure and 12 months. | Thromboembolic complications, artery occlusion, peforation, etc. at periprecedure; AEs and death at periprocedure and 18 months. |