vertebral artery stenosis
Conditions
Interventions
experimental group:Implantation of absorbable drug-eluting vertebral artery stents in stenotic vessels
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Patients proposed for endovascular intervention and prepared for placement of absorbable drug-eluting vertebral artery stents; (2) Patients aged 18 years (inclusive) - 80 years; (3) Patients with severe stenosis (>70%) of the ipsilateral vertebral artery (intracranial segment) in whom transient ischaemic attack (TIA) and non-disabling stroke occurred despite treatment with at least one antiplatelet aggregating drug, and patients with severe stenosis (>70%) of the vertebral artery (extracranial segment); (4) Vascular lesion length =15 mm, with a reference vessel diameter of 2.5 mm - 5.0 mm; (5) Total number of target lesions 1, lesion up to 1 stent implantation; (6) Modified Rankin score (mRS) =3 before the last cerebrovascular event; (7) Patients with at least 1 or more atheromatous plaque risk factors, such as hypertension, diabetes mellitus, hyperlipidemia, and a history of smoking; (8) Patients and their families fully understood the purpose of the study, voluntarily participated in the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe stenosis (>70%) or complete occlusion of vessels outside the site of the combined lesion; (2) Imaging showing complete occlusion of the target lesion, presence of severe calcification, intraluminal thrombus, or diffuse lesions; (3) Previous surgical treatment of the target lesion area or implantation of another permanent stent; (4) Non-atherosclerotic arterial stenosis, e.g., smokers' disease, other known vasculitic diseases, infectious diseases; (5) Combination of other intracranial pathologies (e.g. intracranial haemorrhage, aneurysm, arteriovenous malformation, brain tumour); (6) Patients with bleeding tendency, active peptic ulcer, history of cerebral haemorrhage or subarachnoid haemorrhage; contraindications to antiplatelet and anticoagulant medication, and inability to undergo antithrombotic therapy; (7) Patients with known allergies to heparin, aspirin, clopidogrel, sirolimus, contrast media, racemic polylactic acid (PDLLA), zinc metal, iron metal, and anaesthetic drugs; (8) Have had major surgery within 30 days or will have major surgery within 90 days; (9) Patients with TIA or non-disabling stroke caused by factors other than vertebral artery stenosis (e.g., atrial fibrillation, etc.); (10) Patients with a history of iron overload or iron disorder-related diseases, such as hereditary haemochromatosis; (11) Pregnant or lactating women; (12) Patients with severe cardiac, renal, or hepatic insufficiency or a life expectancy of <2 years; (13) Patients who have participated in other drug or medical device clinical studies prior to enrolment and have not met the primary study endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of in-stent restenosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative stenting success rate; | — |
Countries
China
Contacts
Public ContactLiu Aihua
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed