Investigation of optimal first-line technique of endovascular therapy for acute ischemic stroke

JRCT ID: jRCT1052210091

Registered date:22/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute ischemic stroke
• Date of first enrollment: 30/03/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

1) Combined use of contact aspiration and stent retriever technique
2) Contact aspiration alone

Outcome(s)

• Primary Outcome: Rate of excellent reperfusion (eTICI 2c/3) after single device pass

Secondary Outcome

1) Rate of successful reperfusion (eTICI 2b/2c/3) after single device pass
2) Rate of excellent reperfusion at the end of protocol treatment
3) Rate of successful reperfusion at the end of protocol treatment
4) Time from arterial puncture to excellent reperfusion
5) Time from arterial puncture to successful reperfusion
6) Rate of mRS score 0-2 at 90 days from protocol treatment
7) Rate of mRS score 0-1 at 90 days from protocol treatment
8) EQ-5D-5L score at 90 days from protocol treatment
9) Rate of mRS score 0-2 at 12 months from protocol treatment
10) Rate of mRS score 0-1 at 12 months from protocol treatment
11) EQ-5D-5L score at 12 months from protocol treatment
12) Total reimbursement price of endovascular devices used

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Aged 20 years or older
2) Hospital arrival within 24 hours of onset
3) Acute ischemic stroke
4) No disability prior to the index stroke (modified Rankin Scale 0-2)
5) NIH Stroke Scale score of 6 or higher
6) Occlusion of the interal carotid artery or M1 segment of the middle cerebral artery on CT or MRI at presentation
7) ASPECTS of 6 or higher
8) Written informed consent from the patient or from a relative

Exclude criteria

1) Occlusion of the extracranal internal carotid artery
2) Blood glucose level 50 mg/dL or lower when obtaining consent
3) Allergy to iodinated contrast agents
4) Intracranial hemorrhage on CT/MRI
5) Severe intracranial space occypying effects with midline shift on CT/MRI
6) Clinical evidence of chronic occlusion
7) Multiple occlusions of cerebral arteries
8) Pregnancy of suspected pregnancy
9) Participation in other clinical trials
10) An estimated life expectancy of less than 12 months due to causes other than acute ischemic stroke
11) Severe allergy or hypersensitivity to nickel-titanium alloy, nickel-chromium, platinum-tungsten alloy, or stainless steel
12) Patients with highly tortuous vessels that make it difficult to deliver devices to the target vessel
13) Carotid artery dissection, occlusion of the entire cervical carotid artery, or vasculitis
14) Uncontrollable hypertension (systolic blood pressure of 185 mmHg or higher or diastolic blood pressure of 110 mmHg or higher)
15) Intracranial tumors (except for small meningiomas)
16) Patients on anticoagulant therapy with a PT-INR >3 or an activated partial thromboplastin time >2 times the normal value
17) A platelet count of less than 50,000/micro-L
18) Unable to obtain consent for mechanical thrombectomy as clinical practice
19) Patients who are judged inappropriate for participation in the study by the investigators for any other reason

Related Information

• Primary Sponsor: Toyoda Kazunori
• Source(s) of Monetary Support: Takeda Science Foundation,Intramural Research Fund for Cardiovascular Diseases of the National Cerebral and Cardiovascular Center (20-4-3),Japan Society for the Promotion of Science (23K14790),SENSHIN Medical Research Foundation