Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ische… (NCT06485427) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Selective Intra-Arterial Cooling Infusion Combined With EVT in Acute Ischemic Stroke
China258 participantsStarted 2024-07-03
Plain-language summary
This is a multicenter, randomized, controlled, subject- and assessor-blinded clinical trial. The research objective is to evaluate the safety and efficacy of selective intra-arterial cooling infusion combined with endovascular therapy in the treatment of acute anterior circulation large vessel occlusion stroke. This trial aims to enroll 258 subjects. Patients assigned to the control group will receive best medical management (BMM) and endovascular therapy (EVT). Those in the selective intra-arterial cooling infusion group (IA-SCI group) will undergo selective intra-arterial cold saline infusion, in addition to BMM and EVT. Subjects will be interviewed face-to-face at randomization, 24±6 hours, 48±6 hours after randomization, 7±2 days/discharge. Telephone interviews/ face-to face interviews will be performed at 30±3 days and 90±7 days after randomization. The primary outcome is the distribution of Modified Rankin Score at 90±7days after randomization.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 and ≤80.
. Clinical signs consistent with AIS-LVO in the anterior circulation (intracranial segment of internal carotid artery, M1 segment of middle cerebral artery (MCA) demonstrated by computed tomography angiography (CTA) / magnetic resonance angiography (MRA)/ digital subtraction angiography (DSA)).
. National Institutes of Health Stroke Scale (NIHSS) score (at screening) ≥6 and ≤25.
. Modified Rankin Scale (mRS) score ≤1 before stroke onset.
. Arterial puncture performed within 24 hours of symptom onset or last known well (LKW).
. Written informed consent obtained from the patients or legally authorized representatives.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distribution of Modified Rankin scale
Timeframe: 90 ±7days
Trial details
NCT IDNCT06485427
SponsorBeijing Shijitan Hospital, Capital Medical University
. Baseline CT/MRI reveals the presence of acute infarction in multiple vascular territories.
. CTA/MRA/DSA confirms the presence of arterial dissection.
. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy.
. Known allergies or intolerances to antiplatelet agents, anticoagulants, iodinated contrast, or anesthetics.
. Severe infection (e.g., sepsis) or multiple organ failure.
. Known hereditary or acquired hemorrhagic diathesis; coagulation factor deficiency; recent oral anticoagulant therapy with international normalized ratio (INR)\>3.