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

Not yet recruiting

• Conditions: Atheroscleroses, Cerebral; Intracranial Atherosclerosis; Ischemia Stroke
• Interventions: Device: Balloon-expandable drug-eluting stent

• Registration Number: NCT06614972
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Study Start: 2024-09-30
• Primary Completion: 2025-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
balloon-expandable drug-eluting stent	Balloon-expandable drug-eluting stent	Patients were treated with balloon-expandable drug-eluting stent.

Primary Outcome Measures

Name	Time	Method
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.	12 months after implantation	Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year.

Secondary Outcome Measures

Name	Time	Method
Any cerebral events within 1 year	12 months after implantation	Cerebral events defined as transient ischemic attack (TIA), ischemic stroke, thrombus and death in the territory of the qualifying artery
Periprocedural events	within 30 days after implantation	Periprocedural events defined as transient ischemic attack (TIA), ischemic stroke and all-cause death.
In-stent restenosis(ISR) rate	12 months after implantation	The ISR is defined as \>50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and \>20% absolute luminal loss on angiographic experiment.
Technique success rate	During the procedure	Technique success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of \<30%.
Functional outcome measured by modified Rankin Scale and NIH stroke scale (NIHSS) score	Every year after implantation during 5 years	Modified Rankin Scale (mRS) score and NIHSS score(if need) at every year after implantation during 5 years. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead. A higher score indicates a worse outcome. NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The minimum score is 1 and the maximum score is 20. A higher score indicates a worse outcome.