Treatment for narrowing of vertebral arteries using drug-eluting stents
Official title: Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis in Real-World Clinical Observations: a Prospective, Multicenter, Open-access, Single-arm Clinical Study
Run by Nanfang Hospital, Southern Medical University · NCT05644314 · Data updated 2026-11-12
This study is testing a new type of stent to see if it can help people with narrowed vertebral arteries reduce their risk of strokes and improve their brain health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | May 31, 2026 |
| Study ends | May 31, 2029 |
| Registry record updated | March 14, 2023 |
| Trial ID | NCT05644314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who require a drug-eluting vertebral artery stent and can comply with the study protocols.
✕Probably not a fit
Patients with severe systemic diseases, uncontrolled hypertension, or those who cannot undergo dual antiplatelet therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of a drug-eluting stent system for patients with atherosclerotic vertebral artery stenosis, which can lead to ischemic strokes. It is a prospective, multi-center, open-access, single-arm trial where participants will be monitored for clinical outcomes at 30 days, 6 months, and 12 months post-procedure, with annual follow-ups for up to three years. The study focuses on assessing the long-term efficacy of the stent in reducing the risk of stroke recurrence and improving neurological outcomes.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of stroke recurrence and improve the quality of life for patients with vertebral artery stenosis.
How similar studies have gone: Previous studies have shown that drug-eluting stents can effectively reduce restenosis rates, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old, gender is not limited; 2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems; 3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form. Exclusion Criteria: 1. Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery; 2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery; 3. Gastrointestinal disease with active bleeding; 4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks; 5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents; 6. Life expectancy less than 12 months; 7. the investigator judged patients to be unsuitable for participation in this study.
Where it's running
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Zhong Ji, PHD — Nanfang Hospital, Southern Medical University
- Study coordinator: Zhong Ji, PHD
- Email: jizhong22@hotmail.com
- Phone: 020-62787664
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.