Treatment for narrowing of vertebral arteries using drug-eluting stents
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05644314 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe systemic diseases, uncontrolled hypertension, or those who cannot undergo dual antiplatelet therapy may not benefit from this study.
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 performed: Previous studies have shown that drug-eluting stents can effectively reduce restenosis rates, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.