search
Back to results

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

Primary Purpose

Intracranial Atherosclerosis, Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
drug coated balloon
stent system
Sponsored by
Acotec Scientific Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Atherosclerosis focused on measuring Intracranial Atherosclerosis, Stroke, drug coated balloon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 80 years of age;
  • Patients with refractory symptomatic intracranial atherosclerotic stenosis after drug therapy;
  • Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA);
  • Confirmed by DSA,the diameter of the target vessel is between 2.0mm-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.

Sites / Locations

  • Beijing Tiantan Hospital
  • Nanyang City Central Hospital
  • Shanxi Cardiovascular Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCB group

Stent group

Arm Description

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

use the Intracranial Stent System made by MicroPort.

Outcomes

Primary Outcome Measures

Angiographic restenosis of the target lesion
angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab

Secondary Outcome Measures

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.
target vessel stroke or death event
Stroke (bleeding and ischemia) or death related to target vessels within 30 days postoperatively.
target vessel ischemia stroke event
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively
target vessel death event
Target-vessel related death 31 days to 6 months postoperatively
transient ischemic attack event
transient ischemic attack event transient ischemic attack event
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)
Modified Rankin Scale score
Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome)

Full Information

First Posted
November 3, 2020
Last Updated
October 19, 2023
Sponsor
Acotec Scientific Co., Ltd
Collaborators
Beijing Tiantan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04631055
Brief Title
ACOART Intracranial de Novo:DCB in the Treatment of Symptomatic Intracranial Atherosclerotic de Novo Stenosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acotec Scientific Co., Ltd
Collaborators
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis, Stroke
Keywords
Intracranial Atherosclerosis, Stroke, drug coated balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCB group
Arm Type
Experimental
Arm Description
use intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd.
Arm Title
Stent group
Arm Type
Active Comparator
Arm Description
use the Intracranial Stent System made by MicroPort.
Intervention Type
Device
Intervention Name(s)
drug coated balloon
Intervention Description
paclitaxel coated balloon catheter for intracranial PTA treatment
Intervention Type
Device
Intervention Name(s)
stent system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Angiographic restenosis of the target lesion
Description
angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
device success rate
Description
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.
Time Frame
during procedure
Title
target vessel stroke or death event
Description
Stroke (bleeding and ischemia) or death related to target vessels within 30 days postoperatively.
Time Frame
within 30 days post-procedure
Title
target vessel ischemia stroke event
Description
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively
Time Frame
between 31 days and 6 months post-procedure
Title
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Description
Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively
Time Frame
between 31 days and 6 months post-procedure
Title
target vessel death event
Description
Target-vessel related death 31 days to 6 months postoperatively
Time Frame
between 31 days and 6 months post-procedure
Title
transient ischemic attack event
Description
transient ischemic attack event transient ischemic attack event
Time Frame
at 6 months post-procedure
Title
National Institutes of Health Stroke Scale score
Description
National Institutes of Health Stroke Scale score at 6 months post-procedure(0-42,higher scores mean a worse outcome)
Time Frame
at 6 months post-procedure
Title
Modified Rankin Scale score
Description
Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome)
Time Frame
at 6 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongrong Miao, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
Country
China
Facility Name
Nanyang City Central Hospital
City
Nanyang
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs