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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Intracranial Atherosclerosis; Ischemia Stroke; Atheroscleroses, Cerebral

Treatments: Device: Balloon-expandable drug-eluting stent

Study type: Observational

Funder types: Other

Identifiers

NCT06614972

LY2024-188-B

Details and patient eligibility

About

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.

Full description

This study is a prospective, multi-center, real world, registry study. This study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the C2-C7 segments of the internal carotid artery and V4 artery which with high prevalence of calcified plaques in ICAD.

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

520 participants in 1 patient group

balloon-expandable drug-eluting stent

Description:

Patients were treated with balloon-expandable drug-eluting stent.

Treatment:

Device: Balloon-expandable drug-eluting stent