Vertebral Artery StenosisM Short DAPTNCT06683300
Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
An observational study of Vertebral Artery Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China. 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?
- DAPT for 3 months after vertebral artery stenting
- How many people
- 520 participants
- Where
- 1 siteChina
- Study dates
- Nov 2024to Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents.
Who may be able to join
- Age ≥18 years old, gender unlimited;
- Based on clinical and imaging evidence, the investigators identified patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents;
- Patients or their guardians sign informed consent.
Who cannot join
- Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;
- Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;
- Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;
- Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;
- Interventional or surgical procedures are planned within 90 days;
- Known contraindications to heparin, rapamycin, anesthesia and contrast agents;
- Life expectancy is less than 12 months;
- The researcher considers it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital
Beijing
Baixue Jia, MD, +86-15010125093, beckyberry@163.com
About this study
This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China.
Currently, there is no consensus regarding the duration of DAPT after drug-eluting stent treatment for vertebral artery stenosis(VAS). The objective of this study is to standardize clinical medication by shortening the duration of DAPT, thereby reducing the bleeding risk and medication burden for patients, while ensuring that there is no increase in ischemic events.
Read the detailed description
As the drug-eluting stents (DES) with indications for vertebral artery treatment have been officially approved in China, DES has gradually been widely used in the treatment of vertebral artery stenosis. There is increasing clinical attention towards the duration of dual antiplatelet therapy (DAPT) following stenting.
Currently, there is limited evidence regarding the optimal DAPT duration following endovascular treatment for vertebral artery stenosis. Therefore, clinical practice typically relies on experiences derived from treatments for coronary, carotid, or lower limb artery diseases, with a conventional recommendation of 6 to 12 months of antiplatelet therapy post-stent implantation.
Evidence obtained from coronary stents shows that the short-term DAPT strategy of 1-3 months after PCI in the new generation of DES can significantly reduce the incidence of severe bleeding without increasing ischemic events compared with the standard DAPT strategy of 7-12 months, especially for non-acute elective surgery patients who are similar to those with vertebral artery stenosis stents.
This study employs new-generation Co-Cr fluoropolymer DES to evaluate the balance between ischemic and bleeding complications by shortening the DAPT duration, with the ultimate aim of maximizing patient benefits.
- Conditions
- Vertebral Artery Stenosis
- Being tested
- DAPT for 3 months after vertebral artery stenting
- Keywords
- vertebral artery stent, dual antiplatelet duration, symptomatic vertebral artery atherosclerotic stenosis
- Medical subject headings
- Vertebrobasilar Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPT for 3 months after vertebral artery stentingDrug
After implantation of a drug-eluting stent in the vertebral artery, dual antiplatelet therapy (DAPT) were administered for 3 months. The types of antiplatelet medications are not limited, with the standard regimen consisting of aspirin 100 mg once daily combined with either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily. Additional antiplatelet agents such as indobufen may also be considered acceptable.
| Study group | Role | What they receive |
|---|---|---|
| 3 months DAPT | dual antiplatelet therapy (DAPT) for 3 months Receives: Drug: DAPT for 3 months after vertebral artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ischemic stroke in the territory of the target artery within 1 year
The primary endpoint was defined as occurrence of ischemic stroke events in the target arterial territory, excluding transient ischemic attacks.
Measured: 12 months after stent implantation
Secondary outcomes (10)
Occurrence of Periprocedural events
Periprocedural events defined as occurrence of transient ischemic attack (TIA), ischemic stroke and all-cause death.
Measured: within 30 days after stent implantation
Occurrence of Bleeding Events within 1 year
Bleeding events are defined as gastrointestinal hemorrhage, gingival hemorrhage, conjunctival hemorrhage, intraocular hemorrhage, nasal hemorrhage, hemoptysis, cerebral hemorrhage(such as subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), or subdural hematoma (SDH)), bleeding at puncture sites, intraperitoneal bleeding, and skin bleeding, among others.
Measured: 12 months after stent implantation
Occurrence of TIA events related to the target territory within 1 year
The outcome defined as temporary neurological symptoms caused by TIA that related to the target lesion judged by physicians.
Measured: 12 months after stent implantation
Occurrence of disabling and fatal stroke events within 1 year
Disabling and fatal stroke are defined as stroke that results in severe disability or death.
Measured: 12 months after stent implantation
AEs and SAEs
Measured: in 12 months
Occurrence of residual stenosis after the procedure
Degree of residual stenosis was measured and calculated according to the methods of the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial.
Measured: At the end of the procedure
Rate of In-stent restenosis (ISR) within 12 months
The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss.
Measured: 12 months after stent implantation
modified Rankin Scale score at 1 year
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;
- No significant disability;
- Slight disability;
- Moderate disability;
- Moderately severe disability;
- Severe disability; 6 -Dead. A higher score indicates a poorer outcome.
Measured: 12 months after stent implantation
The National Institutes of Health Stroke Scale (NIHSS) score at 1 year
NIHSS is a standardized scoring system used to measure the severity of neurological deficits caused by a stroke. It assesses various aspects of brain function, including consciousness, vision, sensation, movement, speech, and language. The scale ranges from 0 to 42, with higher scores indicating more severe strokes.
Measured: 12 months after stent implantation
EQ-5D score at 1 year
The EQ-5D is a standardized questionnaire used to measure health-related quality of life. It assesses five dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression. Each dimension is scored from 1 to 3, with 1 being no problems, 2 being some or moderate problems, and 3 being severe or extreme problems.
Measured: 12 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Beijing Tiantan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683300
- Sponsor's protocol ID
- KY2024-158-02
- Acronym
- M Short DAPT
- Status last verified
- Sep 2024
- First submitted
- 5 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
- ClinicalTrials.gov ID
- NCT06683300
- Acronym / sponsor ID
- M Short DAPT / KY2024-158-02
- Conditions
- Vertebral Artery Stenosis
- Keywords
- vertebral artery stent, dual antiplatelet duration, symptomatic vertebral artery atherosclerotic stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Nov 2024 (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.
This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China.
Currently, there is no consensus regarding the duration of DAPT after drug-eluting stent treatment for vertebral artery stenosis(VAS). The objective of this study is to standardize clinical medication by shortening the duration of DAPT, thereby reducing the bleeding risk and medication burden for patients, while ensuring that there is no increase in ischemic events.
Detailed description
As the drug-eluting stents (DES) with indications for vertebral artery treatment have been officially approved in China, DES has gradually been widely used in the treatment of vertebral artery stenosis. There is increasing clinical attention towards the duration of dual antiplatelet therapy (DAPT) following stenting.
Currently, there is limited evidence regarding the optimal DAPT duration following endovascular treatment for vertebral artery stenosis. Therefore, clinical practice typically relies on experiences derived from treatments for coronary, carotid, or lower limb artery diseases, with a conventional recommendation of 6 to 12 months of antiplatelet therapy post-stent implantation.
Evidence obtained from coronary stents shows that the short-term DAPT strategy of 1-3 months after PCI in the new generation of DES can significantly reduce the incidence of severe bleeding without increasing ischemic events compared with the standard DAPT strategy of 7-12 months, especially for non-acute elective surgery patients who are similar to those with vertebral artery stenosis stents.
This study employs new-generation Co-Cr fluoropolymer DES to evaluate the balance between ischemic and bleeding complications by shortening the DAPT duration, with the ultimate aim of maximizing patient benefits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 months DAPT | – | Drug: DAPT for 3 months after vertebral artery stentingdual antiplatelet therapy (DAPT) for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents.
Key inclusion criteria (3 listed)
- Age ≥18 years old, gender unlimited;
- Based on clinical and imaging evidence, the investigators identified patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents;
- Patients or their guardians sign informed consent.
Key exclusion criteria (8 listed)
- Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;
- Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;
- Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;
- Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;
- Interventional or surgical procedures are planned within 90 days;
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 |
|---|---|---|
| DAPT for 3 months after vertebral artery stentingAfter implantation of a drug-eluting stent in the vertebral artery, dual antiplatelet therapy (DAPT) were administered for 3 months. The types of antiplatelet medications are not limited, with the standard regimen consisting of aspirin 100 mg once daily combined with either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily. Additional antiplatelet agents such as indobufen may also be considered acceptable. | Drug | 3 months DAPT |
Primary outcome
Occurrence of ischemic stroke in the territory of the target artery within 1 year
Time frame: 12 months after stent implantation
The primary endpoint was defined as occurrence of ischemic stroke events in the target arterial territory, excluding transient ischemic attacks.
10 secondary outcomes
Occurrence of Periprocedural events
Time frame: within 30 days after stent implantation
Occurrence of Bleeding Events within 1 year
Time frame: 12 months after stent implantation
Occurrence of TIA events related to the target territory within 1 year
Time frame: 12 months after stent implantation
Occurrence of disabling and fatal stroke events within 1 year
Time frame: 12 months after stent implantation
AEs and SAEs
Time frame: in 12 months
Occurrence of residual stenosis after the procedure
Time frame: At the end of the procedure
Rate of In-stent restenosis (ISR) within 12 months
Time frame: 12 months after stent implantation
modified Rankin Scale score at 1 year
Time frame: 12 months after stent implantation
The National Institutes of Health Stroke Scale (NIHSS) score at 1 year
Time frame: 12 months after stent implantation
EQ-5D score at 1 year
Time frame: 12 months after stent implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site 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 Stenosis, run by Beijing Tiantan Hospital 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baixue Jia, MD (+86-15010125093, beckyberry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of ischemic stroke in the territory of the target artery within 1 year (time frame: 12 months after stent implantation). 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 12 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.