Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry) (NCT06614972) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)
520 participantsStarted 2024-09-30
Plain-language summary
To study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. According to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery V4 segment or internal carotid artery C2-C7 segment, and the degree of diseased arterial stenosis is between 70%\~99% (WASID method).
✓. Patients have more than 1 episode of symptoms including stroke or transient ischemia attack (TIA) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments).
✓. Patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on.
✓. Baseline mRS score ≤3.
✓. Patient or guardian signs informed consent.
Exclusion criteria
✕. Patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery.
✕. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
✕. Gastrointestinal disease with active bleeding.
✕. Myocardial infarction or massive cerebral infarction within 2 weeks.
What they're measuring
1
Any stroke or death within 30 days of implantation or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.