Vertebral Artery Origin StenosisNCT03311360
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
An observational study of Vertebral Artery Origin Stenosis, run by Chinese Society of Interventional Radiology at 9 sites in China.
Trial summary
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vertebral Artery Origin Stenosis
- What is being tested?
- drug-coated balloon and bare metal stent
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jan 2018to 1 Oct 2020
- Phase
- Observational
- 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
Study population: patients meet all of the inclusion criteria and none of the excusion criteria
Who may be able to join
- aged between 18 and 80 years old;
- TIA or non-disabling ischaemic stroke of the posterior circulation;
- symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
- stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
- NIHSS≤ 6;
- score on the modified Rankin scale ≤ 3.
Who cannot join
- Active bleeding or coagulation disorders or severe renal/liver impairment
- allergy to iodinated contrast agent or related medicines;
- acute stroke in 3 weeks
- more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
- a potential cause of stenosis other than atherosclerosis
- Severe stenosis was found in the anterior circulation artery(>70%)
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- intracranial hemorrhage or hemorrhagic stroke, intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm in 30 days;
- ISR patients;
- Severe calcification lesion；
- obvious thrombosis in vessel;
- pregnancy;
- a potential cause of TIA or minor stroke other than stenosis in a vertebral artery.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Anzhen hospital
Beijing
The rockets army general hospital
Beijing
The first affiliated hospital of Dalian medical university
Dalian
The first affiliated hospital of Harbin medical university
Harbin
The first hospital of Jilin university
Jilin City
Shengjing Hosptal of china medical university
Shenyang
Henan provincial peoples hospital
Zhengzhou
The first hospital of zhengzhou university
Zhengzhou
Zhengzhou center hospital
Zhengzhou
About this study
Official title: Chinese Society of Interventional Radiology
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
- Conditions
- Vertebral Artery Origin Stenosis
- Being tested
- drug-coated balloon, bare metal stent
- Keywords
- vertebral artery origin stenosis, drug-coated balloon, stenting, medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloonDevice
Orchid and Dahlia DCB
bare metal stentDevice
any type of bare metal stent
| Study group | Role | What they receive |
|---|---|---|
| drug-coated balloon | patients with vertebral artery origin stenosis treated with drug-coated balloons Receives: Device: drug-coated balloon | |
| bare metal stent | patients with vertebral artery origin stenosis treated with bare metal stent Receives: Device: bare metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician
Measured: 12 months
Secondary outcomes (7)
lumen loss at 6 months
lumen loss measured by doppler untrasound
Measured: 6 months
lumen loss at 12 months
lumen loss measured by doppler untrasound
Measured: 12 months
restenosis at 6 months
restenosis was assessed by doppler untrasound
Measured: 6 months
restenosis at 12 months
restenosis was assessed by doppler untrasound
Measured: 12 months
traget lesion revascularizition at 12 months
traget lesion revascularizition including envascular intervention and Surgery
Measured: 12 months
Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days
safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke diagnosed by investigators within 30 days after start of the treatment
Measured: 30 days
stent fracture rate at 12 months
stent fracture was assessed by DSA
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 posted17 Oct 2017
- Study start1 Jan 2018
- Primary completion1 Feb 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Artery Origin StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Society of Interventional Radiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311360
- Sponsor's protocol ID
- CSIR01
- Status last verified
- Jan 2019
- First submitted
- 9 Oct 2017
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Society of Interventional Radiology
- ClinicalTrials.gov ID
- NCT03311360
- Acronym / sponsor ID
- CSIR01
- Conditions
- Vertebral Artery Origin Stenosis
- Keywords
- vertebral artery origin stenosis, drug-coated balloon, stenting, medical treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Chinese Society of Interventional RadiologyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Oct 2017 (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.
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug-coated balloon | – | Device: drug-coated balloonpatients with vertebral artery origin stenosis treated with drug-coated balloons |
| bare metal stent | – | Device: bare metal stentpatients with vertebral artery origin stenosis treated with bare metal stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients meet all of the inclusion criteria and none of the excusion criteria
Key inclusion criteria (6 listed)
- aged between 18 and 80 years old;
- TIA or non-disabling ischaemic stroke of the posterior circulation;
- symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
- stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
- NIHSS≤ 6;
Key exclusion criteria (12 listed)
- Active bleeding or coagulation disorders or severe renal/liver impairment
- allergy to iodinated contrast agent or related medicines;
- acute stroke in 3 weeks
- more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
- a potential cause of stenosis other than atherosclerosis
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 balloonOrchid and Dahlia DCB | Device | drug-coated balloon |
| bare metal stentany type of bare metal stent | Device | bare metal stent |
Primary outcome
Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
Time frame: 12 months
vascular death,non-fatal myocardial and non-fatal stroke diagnosed by specialist physician
7 secondary outcomes
lumen loss at 6 months
Time frame: 6 months
lumen loss at 12 months
Time frame: 12 months
restenosis at 6 months
Time frame: 6 months
restenosis at 12 months
Time frame: 12 months
traget lesion revascularizition at 12 months
Time frame: 12 months
Incidence of safety events including vascular death,non-fatal myocardial infarction, or non-fatal stroke in 30 days
Time frame: 30 days
stent fracture rate at 12 months
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 3 Aug 2021.
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Vertebral Artery Stenosis
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Artery Origin Stenosis, run by Chinese Society of Interventional Radiology at 9 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 12 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 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months (time frame: 12 months). 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 3 Aug 2021.