A study on the safety and efficacy of a dilator for recanalization therapy for major cerebral artery occlusion

A study on the safety and efficacy of a dilator for recanalization therapy for major cerebral artery occlusion - TG-DL-1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs052220101

Enrollment

Registered

2022-10-05

Start date

2022-11-30

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

Using unapproved equipment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Acute ischemic stroke diagnosed as caused by atherosclerotic lesions (2)Obstruction of major cerebral arteries (3)Patients who cannot recanalize the occluded blood vessel with existing treatment 1,Patients who did not achieve recanalization with existing treatment 2,Those who are judged by the attending physician to be unsuitable for recanalization therapy with existing treatment (4)Those who are 20 to 80 years old at the time of consent (5)Subjects with preonset mRS score of 0-2 (6)Those who have obtained written consent Existing treatment:balloon angioplasty,mechanical thrombectomy,Intravenous t-PA

Exclusion criteria

Exclusion criteria: (1)Persons with hypersensitivity to nickel and titanium (2)Those who are judged difficult to follow up for 90 days, such as an estimated life expectancy of less than 90 days. (3)Participating in other clinical trials or interventional studies (4)Persons who are judged inappropriate for participation in this study by the principal investigator or co-investigator

Design outcomes

Primary

Measure	Time frame
Incidence rate of adverse events caused by study device up to7 days after surgery 1,Distal embolization 2.Symptomatic vascular dissection,Symptomatic vasospasm,vascular perforation 3,hemorrhagic stroke	—

Secondary

Measure	Time frame
1.Effective reperfusion rate immediately after surgery(mTICI) 2.Rate of blood flow resumption immediately after surgery(AOL,WASID) 3.Lesion patency 7 days after surgery 4,Percentage of ischemic stroke recurrence or reocclusion of treated vessels within 7 days after surgery 5,Proportion of ischemic stroke recurrence or reocclusion of treated vessels within 90 days after surgery 6.Percentage of daily living independence(mRS) 0-2 at 90 days after surgery 7.Proportion of additional treatments during surgery	—

Measure

Time frame

1.Effective reperfusion rate immediately after surgery(mTICI) 2.Rate of blood flow resumption immediately after surgery(AOL,WASID) 3.Lesion patency 7 days after surgery 4,Percentage of ischemic stroke recurrence or reocclusion of treated vessels within 7 days after surgery 5,Proportion of ischemic stroke recurrence or reocclusion of treated vessels within 90 days after surgery 6.Percentage of daily living independence(mRS) 0-2 at 90 days after surgery 7.Proportion of additional treatments during surgery

—

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