Ischemic StrokeNCT03910166
AcoArt VI / Vertebral Artery Ostium Stenosis in China
A study testing drug-coated balloon catheter（Orchid, Acotec） and Intracranial artery stent system（APOLLO） in people with Ischemic Stroke and Transient Ischemic Attack, run by Acotec Scientific Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- drug-coated balloon catheter（Orchid, Acotec） and Intracranial artery stent system（APOLLO）
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2020to 1 Oct 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
- aged between 18 and 80 years old
- symptomatic VAO stenosis refractory to AMM (aggressive medical management)
- etiology of VAOS was atherosclerosis
- the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
- Target lesion has stenosis ≥ 70% evidenced by angiography
- Score on the modified Rankin scale ≤ 3
- NIHSS≤ 6
- Patients have signed informed consent
Who cannot join
- In-stent restenosis in vertebral artery
- Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
- Tortuous or variable vessels
- distal serial stenosis or distal vascular dysplasia of the stenosis segment
- Non-atherosclerotic arterial stenosis
- Non-vertebral artery stenosis caused TIA or stroke
Show all 20Show fewer
- intracranial stent implantation within 12 months
- Intracranial hemorrhage occurred within 3 months
- Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure
- Active bleeding or coagulation disorders
- Serious liver/kidney damage, not suitable for routine surgical treatment
- Myocardial infarction or extensive cerebral infarction occurred within 2 weeks
- Uncontrolled high blood pressure
- Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm
- Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc
- Life expectancy shorter than 1 years
- Patients whit cognitive impairment or mental disorders
- Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc
- Pregnant and lactating women
- Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
Read the detailed description
Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Being tested
- drug-coated balloon catheter（Orchid, Acotec）, Intracranial artery stent system（APOLLO）
- Keywords
- drug eluting balloon catheter, stenting
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloon catheter（Orchid, Acotec）Procedure or surgery
After predilation, using drug-coated balloon catheter to cover the whole treated segment
Intracranial artery stent system（APOLLO）Procedure or surgery
stent assisted angioplasty
| Study group | Role | What they receive |
|---|---|---|
| DCB group | Experimental | use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm Receives: Procedure: drug-coated balloon catheter（Orchid, Acotec） |
| BMS group | Active comparator | use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group Receives: Procedure: Intracranial artery stent system（APOLLO） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of target lesion restenosis
Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months
Measured: 12Months
Rate of device success
DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.
Measured: during the operation
Secondary outcomes (3)
Rate of device success
DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.
Measured: during the operation
Incidence of hemorrhagic stroke and posterior circulation ischemic stroke
incidence of hemorrhagic stroke and posterior circulation ischemic stroke within 12 months
Measured: 12 Months
Incidence of transient ischemic attack of posterior circulation
incidence of transient ischemic attack of posterior circulation within 12 months
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start6 Jan 2020
- Primary completion7 Jul 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, PhD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910166
- Sponsor's protocol ID
- Acotec-06
- Status last verified
- Jan 2024
- First submitted
- 9 Apr 2019
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo J, Jiang C, Wang H, Peng R, Wang T, Kuai D, Liang G, Wang F, Wang S, Xu C, Chen W, Deng J, Hu X, Wan S, Li B, Yin B, Du Y, Cheng G, Wan J, Chen X, Wang Y, Jiao L; DCB-VAOS Trial Investigators. Effect of drug-coated balloon in patients with severe vertebral artery origin stenosis: A multicenter randomized controlled trial. Int J Stroke. 2026 Mar;21(3):362-371. doi: 10.1177/17474930251377055. Epub 2025 Oct 9.
PubMed 41067866Wang Y, Ma Y, Gao P, Chen Y, Yang B, Feng Y, Jiao L. Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:579238. doi: 10.3389/fneur.2020.579238. eCollection 2020.
PubMed 33584491
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
- Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of Vertebral Artery Ostium Stenosis
- ClinicalTrials.gov ID
- NCT03910166
- Acronym / sponsor ID
- Acotec-06
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Keywords
- drug eluting balloon catheter, stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 10 Apr 2019 (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 this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
Detailed description
Vertebral Artery Origin Stenting is an established alternative to open surgical bypass for the treatment of Vertebral Artery Ostium Stenosis .
DEBs are designed to promote arterial patency by reducing neointimal proliferation.
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 | Procedure: drug-coated balloon catheter（Orchid, Acotec）use DEB catheter(trade name:Orchid/Dhalia) to treat the stenosis or occlusion in Vertebral Artery Ostium Stenosis of experimental arm |
| BMS group | Active comparator | Procedure: Intracranial artery stent system（APOLLO）use Intracranial artery stent system(trade name:Apollo) to treat stenosis or occlusion in Vertebral Artery Ostium Stenosis of control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged between 18 and 80 years old
- symptomatic VAO stenosis refractory to AMM (aggressive medical management)
- etiology of VAOS was atherosclerosis
- the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
- Target lesion has stenosis ≥ 70% evidenced by angiography
Key exclusion criteria (20 listed)
- In-stent restenosis in vertebral artery
- Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
- Tortuous or variable vessels
- distal serial stenosis or distal vascular dysplasia of the stenosis segment
- Non-atherosclerotic arterial stenosis
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-coated balloon catheter（Orchid, Acotec）After predilation, using drug-coated balloon catheter to cover the whole treated segment | Procedure or surgery | DCB group |
| Intracranial artery stent system（APOLLO）stent assisted angioplasty | Procedure or surgery | BMS group |
Primary outcome
Rate of target lesion restenosis
Time frame: 12Months
Target Lesion Restenosis（diameter stenosis ≥50%） under DSA at 12 Months or diamater stenosis ≥50% under DSA before Target Lesion Revascularization within 12 Months
Rate of device success
Time frame: during the operation
DEB group: DEB catheter can reach the target lesions, expand as expected (not broken),and withdraw successfully. BES group: the stenosis rate of proximal outflow less than 50% with intervention and no ischemia or hemorrhage occurred.
3 secondary outcomes
Rate of device success
Time frame: during the operation
Incidence of hemorrhagic stroke and posterior circulation ischemic stroke
Time frame: 12 Months
Incidence of transient ischemic attack of posterior circulation
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 41067866Luo J, Jiang C, Wang H, Peng R, Wang T, Kuai D, Liang G, Wang F, Wang S, Xu C, Chen W, Deng J, Hu X, Wan S, Li B, Yin B, Du Y, Cheng G, Wan J, Chen X, Wang Y, Jiao L; DCB-VAOS Trial Investigators. Effect of drug-coated balloon in patients with severe vertebral artery origin stenosis: A multicenter randomized controlled trial. Int J Stroke. 2026 Mar;21(3):362-371. doi: 10.1177/17474930251377055. Epub 2025 Oct 9.
- Derived from this study: PubMed 33584491Wang Y, Ma Y, Gao P, Chen Y, Yang B, Feng Y, Jiao L. Paclitaxel Coated Balloon vs. Bare Metal Stent for Endovascular Treatment of Symptomatic Vertebral Artery Origin Stenosis Patients: Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Jan 18;11:579238. doi: 10.3389/fneur.2020.579238. eCollection 2020.
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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.
Liqun Jiao, PhD study chair
Xuanwu Hospital, Beijing
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-coated balloon catheter（Orchid, Acotec） and Intracranial artery stent system（APOLLO） in people with Ischemic Stroke and Transient Ischemic Attack, 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 20 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 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?
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?
Rate of target lesion restenosis (time frame: 12Months). 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 NCT03910166, which also lists 2 linked publications.
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.