A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications

A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications - A randomized controlled trial to investigate the effect of systemic heparinization with or without intravenous heparin administration during flow diverter and Woven EndoBridge Device placement on ischemic and bleeding complications

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060109

Enrollment

200

Registered

2025-12-19

Start date

2025-10-29

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

unruptured aneurysm

Interventions

A group that undergoes systemic heparinization during flow diverter or W-EB placement for unruptured cerebral aneurysms Group without systemic heparinization during flow diverter or W-EB placement for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cerebral aneurysms eligible for Flow diverter placement are wide-neck aneurysms with a maximum diameter of 5mm or more and a neck diameter of 4mm or more, depending on the indications for each flow diverter. They must be unruptured or ruptured for more than 42 days. Aneurysms eligible for W-EB placement are wide-neck (defined as a neck diameter of 4mm or more or a dome/neck ratio of less than 2m) intracranial aneurysms located at the bifurcation of the anterior or posterior circulation. Eligible patients are limited to non-pregnant women aged 20 years or older.

Exclusion criteria

Exclusion criteria: Patients who are taking anticoagulants due to a history of atrial fibrillation, deep vein thrombosis, or other medical diseases will be excluded.

Design outcomes

Primary

Measure	Time frame
- Presence or absence of ischemic complications - Presence or absence of bleeding complications - Puncture site problems (presence or absence of pseudoaneurysm, recompression of the puncture site, presence or absence of AV shunt, presence or absence of protamine reversal, etc.) - DWI positive rate and number of lesions (by size) on postoperative head MRI - mRS at 3 months after surgery	—

Countries

Japan

Contacts

Public ContactTakashi Fujii

Fukuoka Neurosurgical Hospital Department of Neurosurgery

takashigreengreen@gmail.com092-558-0081

Outcome results

None listed

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