Intracranial AtherosclerosisNCT04627870
ACOART Intracranial ISR Pilot:Intracranial DCB in the Treatment of Intracranial In-stent Restenosis
A study testing drug (paclitaxel) coated balloon and PTA balloon in people with Intracranial Atherosclerosis and Stroke, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis. 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 (paclitaxel) coated balloon and PTA balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to 30 Dec 2025
- 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
- Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss
- presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
- asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score <3 on DSA.
- the diameter of target vessel is 2.0-4.5mm
- there is only one intracranial ISR lesion per subject
- 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;
- any history of brain parenchyma 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)
- patients with thrombus in target vessels.
- in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.
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- Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.
- patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.
- Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.
- 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 heart, lung and other important organs.
- patients with known severe hepatic and renal dysfunction.
- patients with hemoglobin < 100g / L, platelet count < 100,000 / mm3, INR > 1.5or with uncorrectable factors leading to bleeding.
- patients who cannot receive dual antiplatelet therapy due to existing diseases or who are tested to be tolerant to dual antiplatelet therapy.
- 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 are unable to complete follow-up due to cognitive, emotional disorders or mental illness.
- Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programme;
- According to the judgement of the investigator, other situations that are not suitable for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Read the detailed description
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
- Conditions
- Intracranial Atherosclerosis, Stroke
- Being tested
- drug (paclitaxel) coated balloon, PTA balloon
- Keywords
- Intracranial Atherosclerosis, In-stent restenosis, 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 (paclitaxel) coated balloonDevice
use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis
PTA balloonDevice
use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis
| Study group | Role | What they receive |
|---|---|---|
| DCB group | Experimental | use drug (paclitaxel) coated balloon to treat intracranial in-stent restenosis Receives: Device: drug (paclitaxel) coated balloon |
| PTA group | Active comparator | use PTA balloon to treat intracranial in-stent restenosis Receives: Device: PTA balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel stroke or death event
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
Measured: within 30 days post-procedure
Secondary outcomes (6)
device success rate
The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated.
Measured: assessed during procedure
target vessel ischemia stroke event
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery
Measured: between 31days and 12months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure
Measured: between 31 days and 12 months post-procedure
target vessel death event
Target-vessel related death 31 days to 12 months postoperatively
Measured: between 31 days and 12 months post-procedure
National Institutes of Health Stroke Scale score
National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome)
Measured: at 12 months post-procedure
Modified Rankin Score score
Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome)
Measured: at 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start26 May 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Ning Ma, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627870
- Sponsor's protocol ID
- ACOART intracranial ISR pilot
- Status last verified
- Jun 2024
- First submitted
- 4 Nov 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
- ClinicalTrials.gov ID
- NCT04627870
- Acronym / sponsor ID
- ACOART intracranial ISR pilot
- Conditions
- Intracranial Atherosclerosis, Stroke
- Keywords
- Intracranial Atherosclerosis, In-stent restenosis, drug coated balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 26 May 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Detailed description
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB group | Experimental | Device: drug (paclitaxel) coated balloonuse drug (paclitaxel) coated balloon to treat intracranial in-stent restenosis |
| PTA group | Active comparator | Device: PTA balloonuse PTA balloon to treat intracranial in-stent restenosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 to 80 years of age
- Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss
- presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
- asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score <3 on DSA.
- the diameter of target vessel is 2.0-4.5mm
Key exclusion criteria (22 listed)
- Patients with stroke within 2 weeks before procedure;
- any history of brain parenchyma 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)
- patients with thrombus in target vessels.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug (paclitaxel) coated balloonuse drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis | Device | DCB group |
| PTA balloonuse traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis | Device | PTA group |
Primary outcome
Target vessel stroke or death event
Time frame: within 30 days post-procedure
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
6 secondary outcomes
device success rate
Time frame: assessed during procedure
target vessel ischemia stroke event
Time frame: between 31days and 12months post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events
Time frame: between 31 days and 12 months post-procedure
target vessel death event
Time frame: between 31 days and 12 months post-procedure
National Institutes of Health Stroke Scale score
Time frame: at 12 months post-procedure
Modified Rankin Score score
Time frame: at 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning Ma, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug (paclitaxel) coated balloon and PTA balloon in people with Intracranial Atherosclerosis and Stroke, run by Acotec Scientific Co., Ltd at 1 site 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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 1 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Ma, MD (010-59978585, maning_03@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel stroke or death event (time frame: within 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.