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

NCT04631055 | Completed

• 1 other identifier: AcoArt sICAS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Intracranial Atherosclerosis; Stroke

Keywords

Intracranial Atherosclerosis; Stroke; drug coated balloon

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months post-procedure

• 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.

  within 30 days post-procedure

Secondary Outcomes (7)

• Device success rate

  during procedure

• Target vessel ischemia stroke event

  between 31 days and 6 months post-procedure

• Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events

  between 31 days and 6 months post-procedure

• Target vessel death event

  between 31 days and 6 months post-procedure

• Transient ischemic attack event

  at 6 months post-procedure

Study Arms (2)

DCB group

EXPERIMENTAL

use intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd.

Device: drug coated balloon

Stent group

ACTIVE COMPARATOR

use the Intracranial Stent System made by MicroPort.

Device: stent system

Interventions

drug coated balloon DEVICE

paclitaxel coated balloon catheter for intracranial PTA treatment

DCB group

stent system DEVICE

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.

Stent group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (3)

Beijing Tiantan Hospital

Beijing, China

Location

Nanyang City Central Hospital

Nanyang, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, China

Location

Related Publications (1)

• 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. 2025 Feb 25:jnis-2024-022768. doi: 10.1136/jnis-2024-022768. Online ahead of print.

  PMID: 40010849 DERIVED

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Stroke

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 17, 2020
• Study Start: June 4, 2021
• Primary Completion: April 10, 2023
• Study Completion: April 13, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

CN (3)