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Table 1 Characteristics of the Included Studies and Outcome Events

From: Hydrogel coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms: a meta-analysis of randomized controlled trials

Trials

GREAT 2018 (DRKS00003132)

PRET 2017 (NCT00626912)

Poncyljusz’s RCT 2014 (EURR-6928)

HELP 2011 (ISRCTN30531382)

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.

  1. GREAT German-French Randomized Endovascular Aneurysm Trial, PRET Patients prone to Recurrence after Endovascular Treatment, HELP Hydrocoil Endovascular aneurysm occLusion and Packing Study, WFNS World Federation of Neurosurgeons Societies, IA Intracranial aneurysm, AEs Adverse Events, SAEs Severe Adverse Events, AVM arteriovenous malformation, HC hydrogel coil, BPC Bare platinum coil