BS054 Long-term Follow-up

Prospective Study Evaluating long-term Safety and Performance of BS054 Combined with Coil Embolization - BS054 Long-FU

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1090220047

Enrollment

Registered

2010-09-06

Start date

2010-02-18

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

Patients enrolled in the BS054 clinical trial and treated with BS054 combined with coli embolization

Interventions

Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients enrolled in the BS054 clinical trial and treated with BS054 combined with coli embolization. Patients willing to accept follow-up visits and examinations. Patients understand this study and able to give written Informed Consent.

Exclusion criteria

Exclusion criteria: No

Design outcomes

Primary

Measure	Time frame
modified Rankin Scale at 2 years after BS054 stent implantation	—

Secondary

Measure	Time frame
Patency rate at 2 years after BS054 stent implantation Intra-aneurysm blood flow at 2 years after BS054 stent implantation Recanalization and regrowth of aneurysm within two years after BS054 stent implantation Retreatment within 2 years after BS054 stent implantation Adverse event or Malfunction within 2 years after BS054 stent implantation	—

Countries

Japan

Contacts

Public ContactChiaki Sakai, Chun Hee Kim

Kobe City Hospital Organization General Hospital

n.sakai@siren.ocn.ne.jp+81-78-302-4321

Outcome results

None listed

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