AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

Not Applicable

Completed

• Conditions: Intracranial Atherosclerosis; Stroke

• Registration Number: NCT04631055
• Lead Sponsor: Acotec Scientific Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 to 80 years of age;<br><br> - Patients with symptomatic intracranial atherosclerotic stenosis;<br><br> - Patients with intracranial arterial de novo stenosis confirmed by digital<br> subtraction angiography (DSA);<br><br> - Confirmed by DSA,the diameter of the target vessel is between 2.5mm-4.5mm ;<br> according to WASID method, the degree of stenosis of the target lesion is 70%-99%;<br><br> - Baseline mRS score =2;<br><br> - Voluntarily participate in this study and sign the informed consent form.<br><br>Exclusion Criteria:<br><br> - Patients with stroke within 2 weeks before procedure;<br><br> - Patients with stroke caused by perforating artery occlusion;<br><br> - Any history of brain parenchymal or other intracranial subarachnoid, subdural or<br> extradural hemorrhage in the past 30 days;<br><br> - Those who have received thrombolysis within 24 hours before procedure;<br><br> - Deterioration of neurological function within 24 hours before procedure (defined as<br> NIHSS score increased by = 4 points over the baseline);<br><br> - The vascular path showed in angiography is so tortuous that it is difficult to<br> advance catheters to the target lesion or retrieve;<br><br> - Lesions that investigators believe are not suitable for stenting;<br><br> - Patients with thrombus in target vessel;<br><br> - In addition to the target lesion, there are still other de novo lesion or ISR lesion<br> with more than 70% diameter stenosis in intracranial arteries that need to be<br> treated at the same time;<br><br> - After endovascular treatment of the target lesion, there is still a stenosis of more<br> than 50% in the main blood supplying artery or an obstructive lesion in the distal<br> vessel of target lesion;<br><br> - Major surgery (including open femoral artery, aortic or carotid artery surgery)<br> within the past 30 days or planned within 90 days;<br><br> - Patients with renal artery, iliac artery, and coronary artery requiring simultaneous<br> intervention;<br><br> - Combined with intracranial tumor, aneurysm or intracranial arteriovenous<br> malformation;<br><br> - Intracranial artery stenosis caused by non-atherosclerotic lesions, including:<br> arterial dissection, moya-moya disease, vasculitis disease, herpes zoster,<br> varicella-zoster or other viral vascular diseases, neurosyphilis, any Other<br> intracranial infections, any intracranial stenosis related to cerebrospinal fluid<br> cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell<br> disease, neurofibromatosis, central nervous system benign vascular disease,<br> postpartum vascular disease, suspected Vasospasm, suspicious embolism<br> recanalization, etc.;<br><br> - Cardiac stroke or potential cardiogenic thromboembolism, with any of the following<br> cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve<br> stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated<br> cardiomyopathy, spontaneous acoustic imaging of the left atrium;<br><br> - Patients with myocardial infarction within 6 weeks before procedure;<br><br> - Those who cannot tolerate general anesthesia due to insufficiency of important<br> organs such as heart and lungs;<br><br> - Patients with known severe hepatic and renal dysfunction;<br><br> - Patients with hemoglobin<100g/L, platelet count<100×1,000,000,000/L, INR>1.5 or<br> there are uncorrectable factors leading to bleeding(if there are multiple checks,<br> the last one shall prevail);<br><br> - Patients who cannot receive dual antiplatelet therapy due to existing diseases or<br> are tolerant to dual antiplatelet therapy confirmed by relevant test;<br><br> - Patients with known severe allergies or contraindications to heparin, paclitaxel,<br> contrast agents and other related intravascular treatment drugs;<br><br> - Current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood<br> pressure>180mmHg or diastolic blood pressure>110mmHg);<br><br> - Life expectancy <1 year;<br><br> - Pregnant or lactating women;<br><br> - Patients who cannot complete the follow-up due to cognitive, emotional or mental<br> illness;<br><br> - Patients who are participating in other drug/device clinical trials and have not<br> completed all follow-ups required by the programmer;<br><br> - According to the judgement of the investigator, other situations that are not<br> suitable for enrollment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint: Angiographic restenosis of the target lesion;Primary safety endpoint: Target vessel stroke or death event

Secondary Outcome Measures

Name	Time	Method
Device success rate;Target vessel ischemia stroke event;Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events;Target vessel death event;Transient ischemic attack event;National Institutes of Health Stroke Scale score;Modified Rankin Scale score