NCT06614972Not yet recruiting
Balloon-expandable DES for ICAS Registry Study (BDES-ICAS Registry)
Clinical Outcome of Balloon-Expandable Drug-Eluting Stenting For Patients With Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Real-World Registry Study
Source: ClinicalTrials.gov · Last updated 26 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 520 (estimated)
- First submitted
- 20 Sept 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- RenJi Hospital
- Diseases
- Stroke
- NCT number
- NCT06614972
What you commit to
- Study type: Observational
- Planned participants: 520
- From 30 Sept 2024 to the primary completion date, 30 Sept 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery.
Other illness
- 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.
- Gastrointestinal disease with active bleeding.
- Myocardial infarction or massive cerebral infarction within 2 weeks.
- Patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media.
Other
- Life expectancy \<12 months.
- According to the judgement of the investigator, other situations that are not suitable for enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.