Clinical trial NCT04631055: AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Intracranial Drug-coated Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Atherosclerosis
Stroke
Keywords: Intracranial Atherosclerosis
Stroke
drug coated balloon
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2020-11-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.

Detailed description: This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age;
* Patients with symptomatic intracranial atherosclerotic stenosis;
* Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA);
* Confirmed by DSA，the diameter of the target vessel is between 2.5mm-4.5mm ; according to WASID method, the degree of stenosis of the target lesion is 70%-99%;
* Baseline mRS score ≤2;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: Primary efficacy endpoint: Angiographic restenosis of the target lesion
timeFrame: 6 months post-procedure
measure: Primary safety endpoint: Target vessel stroke or death event
timeFrame: within 30 days post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: during procedure
measure: Target vessel ischemia stroke event
timeFrame: between 31 days and 6 months post-procedure
measure: Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
timeFrame: between 31 days and 6 months post-procedure
measure: Target vessel death event
timeFrame: between 31 days and 6 months post-procedure
measure: Transient ischemic attack event
timeFrame: at 6 months post-procedure
measure: National Institutes of Health Stroke Scale score
timeFrame: at 6 months post-procedure
measure: Modified Rankin Scale score
timeFrame: at 6 months post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
city: Nanyang
country: China
facility: Nanyang City Central Hospital
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: