Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)

Launched by RENJI HOSPITAL · Sep 23, 2024

Keywords

ClinConnect Summary

The BDES-ICAS Registry study is a clinical trial that aims to understand how effective a specific type of stent, called a balloon-expandable drug-eluting stent, is in preventing strokes and death in patients with narrowed arteries in the brain. This narrowing, known as intracranial atherosclerosis, can lead to serious problems like strokes. The study will look at patients who have had symptoms related to this condition and will follow their health for up to a year after receiving the stent.

To participate in this trial, patients must be at least 18 years old and have experienced symptoms like strokes or transient ischemic attacks (brief episodes of stroke-like symptoms) despite receiving medical treatments. They should also have significant narrowing in specific arteries in the brain. However, certain health issues may disqualify someone from joining, such as severe bleeding disorders or recent heart attacks. If eligible, participants can expect close monitoring of their health for 30 days after the procedure and regular check-ins for up to a year to see how well the stent is working and if it helps prevent future strokes.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years.
• • 2. 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).
• • 3. 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).
• • 4. 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.
• • 5. Baseline mRS score ≤3.
• • 6. Patient or guardian signs informed consent.
• Exclusion Criteria:
• • 1. 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.
• • 2. Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
• • 3. Gastrointestinal disease with active bleeding.
• • 4. Myocardial infarction or massive cerebral infarction within 2 weeks.
• • 5. Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
• • 6. Life expectancy \<12 months.
• • 7. According to the judgement of the investigator, other situations that are not suitable for enrollment.