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COMPLETEDNA

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

NCT04631055•Acotec Scientific Co., Ltd

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+17 more criteria

Locations (3)

Beijing Tiantan Hospital

Beijing, China

Nanyang City Central Hospital

Nanyang, China

Shanxi Cardiovascular Hospital

Taiyuan, China

Key Dates

Start Date

June 4, 2021

Primary Completion Date

April 10, 2023

Completion Date

April 13, 2023

Last Updated

August 23, 2024

Enrollment

180

ACTUAL participants

Conditions

Intracranial AtherosclerosisStroke

Interventions

drug coated balloon

DEVICE

stent system

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Cerebellar Stimulation for Aphasia Rehabilitation

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