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

JRCT ID: jRCTs052220101

Registered date:05/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: acute ischemic stroke
• Date of first enrollment: 30/11/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Using unapproved equipment

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sakai Nobuyuki
• Secondary Sponsor: Sakai Chiaki
• Source(s) of Monetary Support: T.G. Medical Co. Ltd.