Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old, gender is not limited;

Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;

Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.

Disqualifiers

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;

With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;

Gastrointestinal disease with active bleeding;

Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;

Trial design

Design model

Single group

Treatments tested in this trial

  • The drug-eluting stent

    Device

    Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: Patients with vertebral atherosclerotic stenosis requiring stent implantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of clinical ischemic events

Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion

Time frame
within 1 year

Secondary outcomes

1

Clinical Success Rate

Successful arrival and release of the stent in the target lesion with complete coverage of the lesion and residual stenosis \<30%, no major adverse events (MAE).

Time frame
within 1 year after surgery
2

Major adverse event (MAE) incidence

Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.

Time frame
1 month, 6 months, 12 months, 2 and 3 years
3

Incidence of bleeding events

Access or non access site bleeding

Time frame
30 days and 1 year
4

Incidence of in-stent restenosis

Restenosis: in-stent stenosis rate ≥50% on imaging

Time frame
within 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.