HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS trial): procedural safety and operator-assessed efficacy results.

ABSTRACT:

Background and purpose

Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS.

Materials and methods

Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis.

Results

Four hundre

SUBMITTER: White PM 

PROVIDER: S-EPMC8119017 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature