A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter
2026년 6월 25일 업데이트: GuoQiang Xu, Hebei General Hospital
Balloon Guide Catheter-Assisted Carotid Artery Stenting With Multimodal Cerebral Protection: A Prospective, Multicenter, Randomized Controlled Trial
This prospective, multicenter, randomized controlled study enrolled patients undergoing carotid artery stenting (CAS) with cerebral embolic protection for carotid artery stenosis.
They were randomly assigned to either a combination of proximal balloon occlusion, filter protection, intermediate catheter or filter protection alone.
The study included 132 patients, and the primary endpoint was the number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure.
연구 개요
상세 설명
Carotid artery stenting (CAS) is an established treatment for carotid stenosis, yet the optimal cerebral embolic protection strategy remains uncertain.
This prospective, multicenter, randomized, open-label, controlled trial will enroll 132 patients with symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis, who will be randomly assigned 1:1 to either experimental multimodal protection (Balloon Guide Catheter plus distal filter and intermediate catheter aspiration) or conventional distal filter protection alone.
The primary endpoint is the number of new infarcts on post-procedural diffusion-weighted imaging (DWI) assessed within 48 hours (±24 hours), with secondary endpoints including device success and defect rates, incidences of symptomatic and all intracranial hemorrhage within 48 hours post-procedure, ipsilateral target-vessel stroke, TIA, major adverse events (stroke/death/MI), and adverse/serious adverse events at 30 and 90 days, all-cause mortality at 90 days, changes in mRS score at 30 and 90 days, and procedure-related complications (e.g., dissection, hyperperfusion syndrome).
연구 유형
중재적
등록 (추정된)
132
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Yan Zhao
- 전화번호: 185 0327 2089
- 이메일: zhaoyan2333@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Aged between 18 and 80 years (inclusive), with no gender restriction.
- Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%.
- Suitable for carotid artery stenting.
- Good compliance, voluntarily signed the informed consent form, and able to follow up as required.
Exclusion Criteria:
- Severe tortuosity or calcification of the diseased vessel, preventing device delivery.
- Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery.
- Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery.
- Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery).
- Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months.
- Presence of substantial acute or subacute thrombus adjacent to the lesion.
- mRS > 3.
- Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation.
- Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy.
- Patients with prior stent treatment in the ipsilateral head and neck vessels.
- Patients with end-stage renal failure requiring dialysis.
- Life expectancy less than 6 months.
- Patients unsuitable for magnetic resonance imaging (MRI) for any reason.
- Patients with absolute or relative contraindications to antiplatelet therapy.
- Inability to cooperate with the study due to dementia or mental disorder.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Combined Cerebral Protection (BGC + Filter + intermediate catheter)
Participants in this arm will undergo carotid artery stenting (CAS) with a multimodal cerebral embolic protection strategy, incorporating proximal balloon occlusion via a Balloon Guide Catheter (BGC), distal filter protection, and active aspiration through an intermediate catheter.
|
Balloon guide catheter for proximal flow arrest and debris aspiration during carotid stenting.
|
|
활성 비교기: Standard Protection Group (Filter Alone)
Participants in this arm will undergo carotid artery stenting (CAS) with distal filter protection.
|
Distal embolic filter deployed beyond the stenosis to capture debris during stent placement.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
기간: within 48 hours (±24 hours) post-procedure
|
Total number of new DWI positive lesions on post procedural brain MRI within 48 hours (±24 hours).
New lesions are defined as foci of hyperintensity not seen on baseline DWI (if available), or otherwise as lesions consistent with acute embolic infarction.
|
within 48 hours (±24 hours) post-procedure
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Device Success Rate
기간: during the procedure
|
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
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during the procedure
|
|
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
기간: within 30-day post-procedure
|
The rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke, or myocardial infarction within 30-day post-procedure.
|
within 30-day post-procedure
|
|
Changes in mRS score at 30 days and 90 days post-procedure.
기간: 30 days and 90 days post-procedure
|
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
The range is 0-6 (0 is highest function with no symptoms and 6 is death).
|
30 days and 90 days post-procedure
|
|
Incidence of ipsilateral target vessel stroke at 30 days and 90 days post-procedure.
기간: 30 days and 90 days post-procedure
|
Stroke is defined as an acute neurological deficit of vascular origin lasting ≥24 hours, or lasting <24 hours with neuroimaging evidence of new infarction, occurring in the territory of the treated carotid artery.
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30 days and 90 days post-procedure
|
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Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
기간: 30 days and 90 days post-procedure
|
Transient ischemic attacks (TIA) was defined as transient focal neurological deficit of vascular origin lasting <24 hours with no acute infarct on neuroimaging.
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30 days and 90 days post-procedure
|
|
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
기간: during the procedure
|
Procedure related complications include vessel dissection, hyperperfusion syndrome, access site events, and other adverse events directly attributable to carotid artery stenting (CAS).
|
during the procedure
|
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Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
기간: 30 days and 90 days post-procedure
|
The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
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30 days and 90 days post-procedure
|
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Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
기간: within 48 hours (±24 hours) post-procedure
|
Symptomatic intracranial hemorrhage defined as any intracranial hemorrhage on imaging with new neurological symptoms or NIHSS increase ≥4, or death.
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within 48 hours (±24 hours) post-procedure
|
|
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
기간: within 48 hours (±24 hours) post-procedure
|
Incidence of all intracranial hemorrhage on post-procedural brain imaging within 48 hours.
|
within 48 hours (±24 hours) post-procedure
|
|
Incidence of all-cause mortality within 90 days post-procedure.
기간: 90 days post-procedure
|
Incidence of death from any cause occurring within 90 days following the procedure.
|
90 days post-procedure
|
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Incidence of device defects.
기간: during the procedure
|
The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
|
during the procedure
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Guodong Xu, Hebei General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 6월 25일
QC 기준을 충족하는 최초 제출
2026년 6월 25일
처음 게시됨 (실제)
2026년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 25일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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