A Multicentre, Single-arm Study to Assess the Safety and Efficacy of Recanalisation Therapy for Acute Ischaemic Stroke Using Dilators

JRCT ID: jRCT2052230213

Registered date:29/03/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: acute ischemic stroke
• Date of first enrollment: 01/04/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Deliver therapeutic equipment to lesions using unapproved devices during cerebrovascular treatment

Outcome(s)

Primary Outcome

Efficacy:Percentage of effective reopening of the lesion (mTICI >= 2b) immediately after surgery without other additional treatment.
Safety:Percentage of symptomatic intracranial haemorrhage (worsening NIHSS >= 4*) and adverse events (dissection, perforation, distal embolisation occlusion) attributable to the study device at 24 +- 12 hours of treatment.
**based on the NIHSS at screening.

Secondary Outcome

(1)Proportion of patients who achieved effective recanalisation (mTICI >= 2b) immediately after the procedure with the investigational device
(2)Proportion of additional treatment (including stenting)
(3)Vascular stenosis rate* immediately after the procedure and after additional treatment with the investigational device
*Vessel stenosis rate is measured by the WASID method.
(4)The rate of severe stroke attributable to the investigational device or treatment within 7 days of treatment initiation (worsening NIHSS >= 4* or neurological death) *based on the NIHSS at screening.
(5)The rate of recurrent ischaemic stroke or re-occlusion of the treated vessel within 7 days post-operatively.
(6)Independence in daily living 90 days after surgery (mRS: modified Rankin Scale)
(7)The rate of recurrent ischaemic strokes or re-occlusion of the treated vessel within 90 days post surgery.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

(1) Patients with acute ischaemic stroke diagnosed as caused by arteriosclerotic lesions.
(2) Those with lesions in the main cerebral artery ICA/M1/M2/VA/BA (mTICI 0,1 before initiating endovascular treatment)
(3) Those with vascular stenosis (WASID method) of 50% or more at the lesion site.
(4) Patients aged between 18 and 85 years at the time of consent.
(5) Patients with an mRS of 0-2 before ischaemic stroke.
(6) Persons who are able to give written consent (substitute writing and proxy consent are acceptable)

Exclude criteria

(1)The following patients who are contraindicated for use in the DL-01 investigational device summary
-Patients who are allergic to the metals contained in the device.
-Patients with dissection of the carotid artery, occlusion over the entire carotid artery or vasculitis.
(2)Patients whose estimated life expectancy is less than 90 days at the time of obtaining consent, or for whom 90-day follow-up is deemed difficult.
(3)Persons participating in other clinical trials or interventional studies.
(4)Women who are pregnant or lactating, or who do not intend to use contraception during the trial period.
(5)Any other person whose participation in this clinical trial is determined by the principal investigator or sub-investigator (hereinafter referred to as the principal investigator, etc.) to be inappropriate.

Related Information

• Primary Sponsor: Arakawa Yoshiki
• Secondary Sponsor: T.G.Medical Co.,Ltd.
• Secondary ID(s): Nil known