Vertebral Artery StenosisPhase 2NCT03504657
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
A Phase 2 study testing Drug-coated balloon angioplasty and stenting angioplasty in people with Vertebral Artery Stenosis, run by The First Affiliated Hospital of Zhengzhou University at 2 sites in China.
Trial summary
Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Artery Stenosis
- What is being tested?
- Drug-coated balloon angioplasty and stenting angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 3 May 2018to 30 Apr 2020
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
- Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
- Lesion length of the stenosis >5mm.
- Angioplasty can be performed within two weeks after randomization
- Female subjects of childbearing potential have a negative pregnancy test.
- Signed informed consent prior to entering study
Who cannot join
- Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
- Life expectancy shorter than 2 years
- Vertebral artery stenosis caused by dissection
- Vertebral stenting felt to be technically impracticable
- Previous stenting in randomized artery
- Pre-morbid modified Rankin scale score of greater than 3
- Currently participating or previously participated in any investigational drug or device study within 6 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Nanyang City Center Hospital
Nanyang
Changming Wen, MD
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yajun Lian, MD, 008613838367143, lianyajun369@yahoo.com
About this study
Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.
- Conditions
- Vertebral Artery Stenosis
- Being tested
- Drug-coated balloon angioplasty, stenting angioplasty
- Keywords
- Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting
- Medical subject headings
- Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-coated balloon angioplastyDevice
Angioplasty with a drug-coated angioplasty
stenting angioplastyDevice
Angioplasty with a stenting
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon angioplasty | Experimental | Not described Receives: Device: Drug-coated balloon angioplasty |
| stenting angioplasty | Active comparator | Not described Receives: Device: stenting angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis
Measured: 12 months
Secondary outcomes (4)
The composite of vascular death, myocardial infarction, or any stroke
Measured: within 30 days after the start of treatment
The composite of vascular death, myocardial infarction, or any stroke
Measured: within 12 months after the start of treatment
Death resulting from any cause
Measured: 12 months
Stroke in the supply territory of the symptomatic vertebral artery
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 posted20 Apr 2018
- Study start3 May 2018
- Primary completion1 May 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Artery StenosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504657
- Sponsor's protocol ID
- FAHZU-2018-006
- Status last verified
- May 2018
- First submitted
- 12 Apr 2018
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
- ClinicalTrials.gov ID
- NCT03504657
- Acronym / sponsor ID
- FAHZU-2018-006
- Conditions
- Vertebral Artery Stenosis
- Keywords
- Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 20 Apr 2018 (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.
Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon angioplasty | Experimental | Device: Drug-coated balloon angioplasty |
| stenting angioplasty | Active comparator | Device: stenting angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
- Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
- Lesion length of the stenosis >5mm.
- Angioplasty can be performed within two weeks after randomization
Key exclusion criteria (7 listed)
- Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
- Life expectancy shorter than 2 years
- Vertebral artery stenosis caused by dissection
- Vertebral stenting felt to be technically impracticable
- Previous stenting in randomized artery
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 angioplastyAngioplasty with a drug-coated angioplasty | Device | Drug-coated balloon angioplasty |
| stenting angioplastyAngioplasty with a stenting | Device | stenting angioplasty |
Primary outcome
Restenosis
Time frame: 12 months
4 secondary outcomes
The composite of vascular death, myocardial infarction, or any stroke
Time frame: within 30 days after the start of treatment
The composite of vascular death, myocardial infarction, or any stroke
Time frame: within 12 months after the start of treatment
Death resulting from any cause
Time frame: 12 months
Stroke in the supply territory of the symptomatic vertebral artery
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug-coated balloon angioplasty and stenting angioplasty in people with Vertebral Artery Stenosis, run by The First Affiliated Hospital of Zhengzhou University at 2 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 7 inclusion and 7 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chuanjie Wu, MD (008618911366882, wuchuanjie8557@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restenosis (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 4 May 2018.