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

Stroke Clinical Trial

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 de Novo Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631055
• Other study ID #: ACOART intracranial de novo
• Status: Completed
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: April 13, 2023

Study information

• Verified date: June 2023
• Source: Acotec Scientific Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 13, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Stroke

Intervention

Device:
• drug coated balloon
paclitaxel coated balloon catheter for intracranial PTA treatment
• 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing
China	Nanyang City Central Hospital	Nanyang
China	Shanxi Cardiovascular Hospital	Taiyuan

Sponsors (2)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	target vessel death event	Target-vessel related death 31 days to 6 months postoperatively	between 31 days and 6 months post-procedure
Secondary	transient ischemic attack event	transient ischemic attack event transient ischemic attack event	at 6 months post-procedure
Secondary	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
Secondary	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