Clinical Research Directory

BASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease

This study will explore the safety and efficacy of BASIS technology in ICAS-LVO lesions through a multicenter, prospective, registry, observational single-arm study.By registering intraoperative recanalization using this technique time, recanalization grade, operative thrombectomy times, intraoperative complications perforating branch occlusion, vascular dissection, vascular rupture, Ectopic thrombus, probability of symptomatic intracranial hemorrhage, mRS Score and mortality rate were followed up for 3 months The unique advantages of the application of the assessment BASIS in this type of lesion provide new insights into complex lesions such as ICAS-LVO The thought and operation method can shorten the operation time, improve the good prognosis, reduce the economic burden and reduce the operation Complications make a positive contribution to ensure that patients receive safe, effective and precise treatment.

To Assess the Effectiveness and Safety of Catheter-based Focal Intracranial Hypothermia Combined With Endovascular Reperfusion Therapy for Patients With Acute Anterior Circulation Large Artery Occlusion

A multicenter, prospective, open-label, blinded-endpoint, randomized controlled trial to assess the effectiveness and safety of catheter-based focal intracranial hypothermia combined with endovascular reperfusion therapy for patients with acute anterior circulation large artery occlusion.

Endovascular Therapy for Acute Basilar Artery Occlusion With Large Ischemic Core

Acute basilar artery occlusion is associated with high mortality and severe disability. Previous randomized trials have demonstrated the benefit of endovascular therapy in selected patients with basilar artery occlusion; however, patients with large ischemic core, commonly defined by low posterior circulation Alberta Stroke Program Early CT Score (pc-ASPECTS), remain underrepresented and the benefit-risk profile of endovascular therapy in this subgroup is uncertain. This prospective, multicenter, randomized, open-label, blinded-endpoint trial will evaluate the efficacy and safety of endovascular therapy plus best medical management compared with best medical management alone in patients with acute basilar artery occlusion within 24 hours from symptom onset or last known well and pc-ASPECTS \<7. Eligible participants will be randomized in a 1:1 ratio to receive endovascular therapy plus best medical management or best medical management alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0 to 3 at 90 days.

Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring

This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.

Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE

The goal of this phase II, placebo-controlled intervention study is to investigate whether tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, may have a neuroprotective effect by reducing infarct growth in adults with acute ischemic stroke. The main question it aims to answer is: Does treatment with tocilizumab given before or during endovascular therapy (EVT) reduce infarct growth 72 hours after EVT compared with placebo in adults with acute ischemic stroke? Researchers will compare tocilizumab with placebo to determine whether infarct growth is smaller in participants receiving tocilizumab. Participants will: Receive either a single dose of tocilizumab or placebo before or during EVT. Undergo standard endovascular treatment for acute ischemic stroke. Undergo brain MRI approximately 72 hours after EVT to assess infarct growth. Have clinical assessments and other study-related examinations and follow-up according to the study protocol.

A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well

This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot. The purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke. Participants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment. Participants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2)

This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.

SUPERSTAR: Aspiration vs. Stent Retriever in Anterior Circulation LVO

This is a multicenter, open-label, blinded-endpoint, randomized controlled trial comparing super large bore catheter aspiration versus stent retriever thrombectomy as the first-line technique for anterior circulation large vessel occlusion in acute ischemic stroke. Eligible patients with acute ischemic stroke due to internal carotid artery intracranial segment and/or middle cerebral artery M1 occlusion will be randomized 1:1 to receive either aspiration using a super large bore catheter (inner diameter ≥0.080 inch) or stent retriever thrombectomy (allowing balloon guiding catheters or intermediate catheters with inner diameter \<0.080 inch). The primary outcome is the ordinal modified Rankin Scale score at 90 days post-procedure. Key secondary outcomes include the proportion of patients with mRS 0-2 at 90 days, change in NIHSS at 24 hours and 7 days, and various angiographic and safety endpoints. The trial plans to enroll 708 patients across approximately 30 centers in China. The total study duration is 24-36 months, with each patient participating for 3 months.

Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke

The HOPE-MeVO study aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke due to medium vessel occlusion presenting 4.5 to 24 hours after stroke onset or last known well. Eligible patients will be selected based on CT perfusion imaging and randomly assigned to receive rhPro-UK plus standard medical treatment or standard medical treatment alone. The primary objective is to determine whether rhPro-UK improves functional outcome at 90 days.

Mobilisation After Endovascular Stroke Treatment

The goal of this observational study is to learn how the timing of mobilisation after endovascular thrombectomy (EVT) affects complications in patients with acute ischaemic stroke. The main questions it aims to answer are: Does mobilisation approximately 12 hours after EVT, compared to approximately 24 hours after EVT, affect the risk of complications such as access site haematoma (ASH), venous thromboembolism (VTE), infections, and delirium? How common are these complications after EVT, and which factors are associated with increased risk? Participants undergoing EVT as part of their regular stroke care at two hospitals with different mobilisation routines will be followed during their hospital stay. Researchers will collect information about mobilisation timing, complications, clinical assessments, and medical history using case report forms, electronic health records, and national stroke registries.

Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2

This study is a randomized, double-blind, placebo-controlled clinical trial. Investigators aim to assess the efficacy and safety of interleukin-6 receptor inhibitor combined with endovascular treatment in patients with acute anterior circulation large vessel occlusion stroke.

The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients

This trial will evaluate the efficacy and safety of HRS-4029 compared with placebo in participants with acute ischemic stroke (AIS).

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).

Intra-Arterial Magnesium Therapy After Mechanical Thrombectomy in Acute Ischemic Stroke

The goal of this Phase I unblinded, dose-escalation trial is to evaluate the safety and tolerability of intra-arterial magnesium sulfate injection after mechanical thrombectomy in patients experiencing acute ischemic stroke. This trial is one of the first trials to look at IA administration of magnesium sulfate into at risk brain tissue in a selective and localized fashion.

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

The benefit of intravenous tenecteplase for acute ischemic stroke with unknown time of onset, e.g. wake-up stroke, remains uncertain. This randomized study aims to assess the efficacy and safety of intravenous tenecteplase following non-contrast CT screening for acute ischemic stroke with unknown time of onset.

A Prospective Study to Observe Clinical Outcomes in Patients Receiving Antiplatelet or Anticoagulant Therapy for Cancer-Associated Acute Ischemic Stroke

The goal of this observational study is to learn about the effectiveness and safety of antiplatelet and anticoagulant treatments in people with a history of cancer who have acute ischemic stroke. The main questions it aims to answer are: * Are there differences in the risk of another stroke between people receiving antiplatelet treatment and those receiving anticoagulant treatment? * Are there differences in the risk of bleeding between the treatment groups? * Which clinical characteristics, imaging findings, cancer-related factors, and blood test results are associated with treatment outcomes? Participants will: * Receive antiplatelet treatment, anticoagulant treatment, or a combination of both, as selected by their treating physicians during routine clinical care. * Provide clinical information and blood samples for the study. * Complete follow-up assessments approximately 30, 90, 180, and 360 days after the stroke. Researchers will compare recurrent stroke, bleeding, other blood clot-related events, functional recovery, and survival among participants receiving different antithrombotic treatments. The study will not assign or change participants' treatments.

COOLing of the Ischemic PENumbra in Patients With Acute Ischemic Stroke.

This study will develop and validate a novel, active/conductive combined head and neck cooling system to selectively cool the ischemic penumbra during the acute phase of stroke, reducing neuronal damage and improving stroke outcomes. It complements existing reperfusion therapies offering a scalable neuroprotective option which will have wider implications across diverse healthcare settings. PHASE I: Technology Development \& Test Bench Optimization (Years 1-2) PHASE II: Validation in healthy volunteers (Year 3) PHASE III: Pilot, multicenter, randomized controlled (Phase 2a) trial (Year 4-5):

Blood Pressure Variability and Ischemic Stroke Outcome

The goal of this observational study is to evaluate the role of blood pressure (BPV) variability in patients suffering from acute ischemic stroke. The main questions it aims to answer are: 1. To determine the association of BPV with functional/cognitive outcome after ischemic stroke. 2. To determine a pathophysiologic mechanism of BPV's deleterious effect on functional outcome. 3. To evaluate potential treatment targets to pharmacologically reduce BPV after ischemic stroke.

Safety and Efficacy of Early Non-invasive Brain-Computer Interface-Based Rehabilitation in Acute Ischemic Stroke

This is a single-center, prospective, randomized, sham-controlled pilot clinical study designed to evaluate the efficacy, safety, and feasibility of early non-invasive electroencephalography-based brain-computer interface (EEG-BCI) rehabilitation training in patients with acute ischemic stroke. Eligible participants are adults aged 18 to 80 years with acute ischemic stroke, unilateral upper extremity motor impairment on the dominant-hand side, a baseline Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) score of 10 to 50, and confirmed clinical stability 48 to 72 hours after stroke onset. Participants will be randomly assigned in a 1:1 ratio to receive either real EEG-BCI training plus standard early rehabilitation or sham BCI training plus standard early rehabilitation. Both groups will receive 10 days of training, with two sessions per day and approximately 30 minutes per session. The primary outcome is the change in FMA-UE score from baseline to 30 days after randomization. Secondary outcomes include changes in FMA-UE, Action Research Arm Test (ARAT), National Institutes of Health Stroke Scale (NIHSS), Modified Barthel Index (MBI), and modified Rankin Scale (mRS). Safety outcomes include symptomatic intracranial hemorrhage, any intracranial hemorrhage, neurological deterioration, seizures, falls, cardiovascular events, and training-related adverse events. This pilot study aims to provide preliminary evidence regarding the feasibility, safety, and potential efficacy of early EEG-BCI rehabilitation after acute ischemic stroke and to inform the design of future multicenter randomized controlled trials.

Association Between Circulating BDNF Levels and Cardioembolic Strokes in Patients Treated for Ischemic Stroke

Atrial fibrillation (AF) is associated with serious complications, including embolic strokes, heart failure, and mortality. Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, increases the risk of thrombus formation. Once dislodged from the atrial cavity and traveling to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for atrial cardiomyopathy (ACM) and AF are metabolic syndrome and aging. ACM is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, the investigators aim to address this challenge by examining ACM through the lens of one of its complications: cardioembolic stroke. BDNF (Brain-Derived Neurotrophic Factor) is a neurotrophic factor involved in inflammatory and metabolic processes that may play a key role in the development of these complications. This study explores the association between circulating levels of BDNF and the morphological and metabolic characteristics of ACM, as assessed by cardiac and brain imaging studies

Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke

The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.

A Multicenter, Three-Arm, Open-Label, Endpoint-Blinded Randomized Controlled Trial to Evaluate the Optimal Duration of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke

Acute ischemic stroke is a leading cause of disability and mortality among dults in China. Although intravenous thrombolysis serves as first-line reperfusion therapy, nearly half of patients fail to achieve vascular recanalization. The reocclusion rate ranges from 14% to 34%, and many patients are left with residual neurological deficits. Early antiplatelet therapy initiated after thrombolysis may sustain persistent reperfusion and improve prognosis. However, current guidelines generally recommend delaying antiplatelet treatment until 24 hours post-thrombolysis due to bleeding risks, and direct evidence for the optimal initiation timing remains lacking. Tirofiban is a rapidly acting, short-half-life, reversible glycoprotein IIb/IIIa receptor antagonist. Previous studies indicate its potential benefits and acceptable safety when administered after intravenous thrombolysis. This is a multicenter, three-arm, open-label, endpoint-blinded randomized controlled trial. A total of 1482 non-cardioembolic patients without large or medium vessel occlusion and with residual neurological deficits (NIHSS ≥4) after thrombolysis will be enrolled. Participants will be randomly allocated to the tirofiban 24-hour group, tirofiban 48-hour group, or blank control group. The primary outcome is the proportion of patients with excellent functional outcome defined as modified Rankin Scale (mRS) score 0-1 at 90 days. Symptomatic intracranial hemorrhage and neurological outcomes will also be evaluated. The study aims to determine the optimal duration of tirofiban treatment after thrombolysis and provide high-level evidence for precise interventions in the acute phase of stroke.

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke

This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.