ACOART Intracranial de Novo:DCB in the Treatment of Symptomatic Intracranial Atherosclerotic de Novo Stenosis

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 de Novo Stenosis

The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial de novo stenosis.

Study Overview

• Status: Completed
• Conditions: Stroke; Intracranial Atherosclerosis
• Intervention / Treatment: Device: drug coated balloon; Device: stent system

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongrong Miao, MD; Phone Number: 010-59978585; Email: zhongrongm@163.com

Study Locations

• China
  • Beijing, China
    • Beijing TianTan Hospital
  • Nanyang, China
    • Nanyang City Central Hospital
  • Taiyuan, China
    • Shanxi Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB group; use intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd.	Device: drug coated balloon; paclitaxel coated balloon catheter for intracranial PTA treatment
Active Comparator: Stent group; use the Intracranial Stent System made by MicroPort.	Device: stent system; The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic restenosis of the target lesion	angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device success rate	DCB: The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. Stent: The stent enables successful arrival of the lesion and subsequent release of the stent delivery system for successful withdrawal.	during procedure
target vessel stroke or death event	Stroke (bleeding and ischemia) or death related to target vessels within 30 days postoperatively.	within 30 days post-procedure
target vessel ischemia stroke event	The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively	between 31 days and 6 months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events	Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively	between 31 days and 6 months post-procedure
target vessel death event	Target-vessel related death 31 days to 6 months postoperatively	between 31 days and 6 months post-procedure
National Institutes of Health Stroke Scale score	National Institutes of Health Stroke Scale score at 6 months post-procedure(0-42,higher scores mean a worse outcome)	at 6 months post-procedure
Modified Rankin Scale score	Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome)	at 6 months post-procedure
transient ischemic attack event	transient ischemic attack event transient ischemic attack event	at 6 months post-procedure

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Zhongrong Miao, MD, Beijing TianTan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; drug coated balloon; Intracranial Atherosclerosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: ACOART intracranial de novo

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No