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NCT Number: NCT05644314

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. 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. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
  • Life expectancy less than 12 months;
  • the investigator judged patients to be unsuitable for participation in this study.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of clinical ischemic events

    Time frame: within 1 year

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

Secondary outcomes

  1. Clinical Success Rate

    Time frame: within 1 year after surgery

    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).

  2. Major adverse event (MAE) incidence

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

    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.

  3. Incidence of bleeding events

    Time frame: 30 days and 1 year

    Access or non access site bleeding

  4. Incidence of in-stent restenosis

    Time frame: within 1 year

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

  5. Changes in the modified Rankin scale (mRS) scores

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

    ability to perform daily living,mRS scores ranges 0-6 , the more score the more severe outcome

  6. Change in NIHSS scores

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

    NIHSS scores for neurological deficits

  7. Correlation of risk factors with the occurrence of major adverse events

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

    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.

  8. Correlation of risk factors with the occurrence of restenosis

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

    Thrombosis in study stents

  9. Evaluation of clinical use for relative contraindications

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

    Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients

Study contacts

Contact information is provided by the study sponsor or research team.

Kaibin Huang

CONTACT

15915751065

Zhong Ji, PHD

CONTACT

[email protected]

020-62787664

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Dec 9, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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