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Intracranial AtherosclerosisNCT04631055

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

A study testing drug coated balloon and stent system in people with Intracranial Atherosclerosis and Stroke, run by Acotec Scientific Co., Ltd at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracranial Atherosclerosis, Stroke
What is being tested?
drug coated balloon and stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
3 sitesChina
Study dates
4 Jun 2021to 13 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Tiantan Hospital

    Beijing

  • Nanyang City Central Hospital

    Nanyang

  • Shanxi Cardiovascular Hospital

    Taiyuan

Other trials in China

About this study

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

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

Read the 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.

Being tested
drug coated balloon, stent system
Keywords
Intracranial Atherosclerosis, Stroke, drug coated balloon
Medical subject headings
Intracranial Arteriosclerosis, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug coated balloonDevice

    paclitaxel coated balloon catheter for intracranial PTA treatment

  • stent systemDevice

    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.

Study groups in NCT04631055
Study groupRoleWhat they receive
DCB groupExperimentaluse intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd.
Receives: Device: drug coated balloon
Stent groupActive comparatoruse the Intracranial Stent System made by MicroPort.
Receives: Device: stent system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint: Angiographic restenosis of the target lesion

    Definition of Restenosis:

    1. Post-procedural residual stenosis < 30% of target lesion occurs >50% stenosis within the treated segment at 6 months angiographic follow-up.
    2. Post-procedural residual stenosis 30-50% of target lesion occurs >20% absolute luminal loss within the treated segment at 6 months angiographic follow-up.

    Measured: 6 months post-procedure

  2. Primary safety endpoint: Target vessel stroke or death event

    Stroke (Hemorrhagic stroke and ischemic stroke) or death related to target vessels within 30 days postoperatively.

    Measured: within 30 days post-procedure

Secondary outcomes (7)

  1. Device success rate

    DCB: The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.

    Stent: Successful delivery and deployment of the stent and the delivery system of stent could be retreated successfully.

    Measured: during procedure

  2. Target vessel ischemia stroke event

    The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively

    Measured: between 31 days and 6 months post-procedure

  3. Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events

    Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively

    Measured: between 31 days and 6 months post-procedure

  4. Target vessel death event

    Target-vessel related death 31 days to 6 months postoperatively

    Measured: between 31 days and 6 months post-procedure

  5. Transient ischemic attack event

    transient ischemic attack event transient ischemic attack event

    Measured: at 6 months post-procedure

  6. 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)

    Measured: at 6 months post-procedure

  7. Modified Rankin Scale score

    Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome)

    Measured: at 6 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start4 Jun 2021
  3. Primary completion10 Apr 2023
  4. Study completion13 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631055
Sponsor's protocol ID
AcoArt sICAS
Status last verified
Aug 2024
First submitted
3 Nov 2020
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ma G, Sun D, Jia B, Ling L, Nguyen TN, Sun X, Yu B, Wen C, Cheng T, Chen W, Han J, Han H, Guo G, Yu J, Wei L, Huang R, Mao G, Shen Q, Yang X, Wang B, Luo G, Huo X, Gao F, Mo D, Ma N, Miao Z. Comparison of drug-coated balloon with bare-metal stent in patients with symptomatic intracranial atherosclerotic stenosis: the AcoArt sICAS randomized clinical trial. J Neurointerv Surg. 2026 Jan 13;18(2):500-507. doi: 10.1136/jnis-2024-022768.

    PubMed 40010849

Questions about this trial

What is this clinical trial studying?

A study testing drug coated balloon and stent system in people with Intracranial Atherosclerosis and Stroke, run by Acotec Scientific Co., Ltd at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint: Angiographic restenosis of the target lesion (time frame: 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631055, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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