Safety and efficacy of the stabilizer device using in endovascular therapy

Safety and efficacy of the stabilizer device using in endovascular therapy - SD-01 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2052220056

Enrollment

Registered

2022-06-22

Start date

2022-07-21

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

cerebral aneurysm, cerebral artery stenosis

Interventions

Deliver therapeutic equipment to lesions using unapproved devices during cerebrovascular treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients aged between 20years and 80years old at the time of concent acquisition 2 modified Rankin Scale is 3 or less 3 Patients with cerebral aneurysm or cerebral artery stenosis who cannot deliver therapeutic medical devices by conventional methods including replacement during endovascular treatment 4 patients who concented to the study in writing.

Exclusion criteria

Exclusion criteria: 1.Heparin cannot be administered for medical reasons 2.It is difficult to follow up 7 days after surgery 3.Have a history of severe contrast agent allergies 4.The following patients who are contraindicated in the clinical trial device summary (1) Patients with allergies to metals contained in the investigational equipment The following patients who are contraindicated in the investigational equipment summary (2) Patients with carotid artery dissection, carotid cervical obstruction or vasculitis 5.Participating in other clinical trials 6.Pregnant or breastfeeding, or unwilling to use contraception during the trial (female only) 7.In addition, the investigator or the investigator has determined that it is inappropriate for conducting this clinical trial.

Design outcomes

Primary

Measure	Time frame
Effectiveness assessment:Successful rate of treatment procedure Safety evaluation:Rate of serious adverse events within 7 days of treatment	—

Secondary

Measure	Time frame
1, Rate of serious adverse events within 7 days of treatment 2. Hemorrhagic stroke requiring treatment within 7 days of treatment or until discharge 3, Ischemic stroke requiring treatment within 7 days of treatment or until discharge 4, Arterial dissection requiring treatment that cannot be denied to be related to the investigational device 5, Symptomatic vasospasm that cannot be denied to be related to the investigational device 6, Other serious adverse events that cannot be denied to be related to the investigational device	—

Measure

Time frame

1, Rate of serious adverse events within 7 days of treatment 2. Hemorrhagic stroke requiring treatment within 7 days of treatment or until discharge 3, Ischemic stroke requiring treatment within 7 days of treatment or until discharge 4, Arterial dissection requiring treatment that cannot be denied to be related to the investigational device 5, Symptomatic vasospasm that cannot be denied to be related to the investigational device 6, Other serious adverse events that cannot be denied to be related to the investigational device

—

Contacts

Public ContactUtako Shirono

Kobe City Medical Center General Hospital

ushirono@kcho.jp+81-783024321

Outcome results

None listed

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