Post market surveillance of Tron FX thrombectomy for acute ischemic stroke

Multi center, Prospective registry of Tron FX thrombectomy for acute ischemic stroke - Tron FX PMA in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036228

Enrollment

240

Registered

2019-03-17

Start date

2019-04-01

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

acute ischemic stroke

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: mechanical thrombectomy using Tron FX

Exclusion criteria

Exclusion criteria: no limitation

Design outcomes

Primary

Measure	Time frame
mRS 0-2 at 90days after onset	—

Secondary

Measure	Time frame
1 successful recanalization, TICI 2b-3 2 symptomatic intracranial hemorrhage within 24 hours 3 mortality within 90 days after onset 4 mRS 0-2 or NIHSS 10 or more improvement or back to baseline mRS @90days after onset 5 procedure or device related severe adverse event 6 device failure	—

Countries

Japan

Contacts

Public ContactChiaki Sakai

Kobe City Medical Center General Hospital Center for Clinical Research and Innovation

chiakimk@cronos.ocn.ne.jp078-302-4321

Outcome results