Comparing drug-eluting stenting to medical treatment for vertebral artery stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of drug-eluting stenting compared to best medical treatment for patients with significant stenosis of the extracranial vertebral artery. It aims to recruit patients who have experienced a stroke or transient ischemic attack due to this condition within the last three months. Participants will be randomly assigned to receive either the stenting procedure along with antiplatelet therapy or medical management alone. The study is designed to address previous trials that were underpowered and inconclusive regarding the benefits of stenting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Extracranial vertebral artery (V1-2 segments) has 70% to 99% stenosis (NASCET criteria by angiography), and the diameter of the target vessel ≥ 2.5mm.
3. History of clinical symptoms associated with target vessels within 3 months before randomization, including ischemic stroke (modified Rankin Scale, mRS score ≤ 3) or transient ischemic attack (TIA).
4. With more than two atherosclerotic risk factors such as, hypertension, hyperlipidemia, diabetes, smoking, drinking, obesity, or obstructive sleep apnea (following the 2021 AHA/ASA guidelines).
5. mRS score ≤ 3.
6. Patients or their guardians voluntarily participate of the study and sign the consent form.

Exclusion Criteria:

1. Vertebral artery stenosis caused by non-atherosclerotic lesions, including arterial dissection, Moyamoya disease, vasculitis disease, radiation-induced vascular disease, fibromuscular dysplasia, etc.
2. Tandem extracranial or intracranial severe stenosis or occlusion of the target vessel.
3. History of open surgery or endovascular treatment of the target vessel.
4. Other cerebrovascular diseases that require one-stage open surgery or endovascular therapies.
5. Open surgery or endovascular treatment for other cerebrovascular diseases within 1 month.
6. Patients in whom vertebral anatomy was felt to be technically not feasible for vertebral artery stenting (e.g. access problems).
7. The contralateral vertebral artery and basilar artery have lesions that may be related to the symptoms, and the investigators cannot confirm that the target vessel is the responsible vessel for the symptoms (For example, the ostium of bilateral vertebral artery is severely narrowing, and the diameter of vertebral artery is equal, unable to determine the dominant vertebral artery).
8. Known allergy or contraindication to iodinated contrast media and sirolimus.
9. History of acute ischemic stroke within 7 days.
10. History of intracranial hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or extradural hemorrhage within 6 weeks.
11. Cardioembolic strokes as evident by prior history of strokes in other territories or multi-territory strokes in the presence of risk factors known to be associated with cardiogenic embolism (e.g. atrial fibrillation, left ventricular thrombus or history of myocardial infarction within 6 weeks, etc.).
12. Coagulation dysfunction or hemorrhagic tendency (e.g. INR \> 1.5 and/or platelet count \< 100×10\^9/L).
13. Cannot complete the follow-up due to severe diseases (e.g. serious infections, severe chronic obstructive pulmonary disease, malignancy, dementia, mental illness, uncontrolled server hypertension or diabetes).
14. Women who are pregnant or lactating.
15. According to the judgement of the investigator, other situations, influencing the safety and efficacy evaluation, which make the patient not suitable for enrollment.

Where it's running

• Xuanwu Hospital, Capital Medical University.
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.