Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, registry trial

Efficacy of HydroSoft coil on endovascular treatment for intracranial aneurysms; Multi-center, prospective, registry trial - Japanese HydroSoft Registry (JHSR)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010342

Enrollment

120

Registered

2013-03-28

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial aneurysm

Interventions

Endovascular treatment using HydroSoft coil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) saccular aneurysm 2) unruptured aneurysm or chronic ruptured aneurysm or acute ruptured aneurysm with WFNS Grade I to III 3) maximum diameter 10mm or less 4) HydroSoft coil 50% or more length used 5) 1 year follow-up possible

Exclusion criteria

Exclusion criteria: 1) previously receive endovascular treatment 2) another aneurysm planned to endovascular treatment

Design outcomes

Primary

Measure	Time frame
Recanalization of endovascular treatment using HydroSoft coil within 1 year	—

Secondary

Measure	Time frame
1) Rebleeding after endovascular treatment using HydroSoft coil within 1 year 2) Major adverse event and death after endovascular treatment using HydroSoft coil within 30 days 3) Retreatment of aneurysm after endovascular treatment using HydroSoft coil within 1 year 4) Any stroke after endovascular treatment using HydroSoft coil within 1 year	—

Countries

Japan

Contacts

Public ContactChiaki Sakai

Institute of Biomedical Research and Innovation Neuroendovascular

ibri-net@fbri.org078-304-520

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026