A Randomized Trial of Carotid Artery Stenting With Balloon Guide Catheter
2026年6月25日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (推定)
132
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yan Zhao
- 電話番号：185 0327 2089
- メール：zhaoyan2333@163.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of new infarcts on cerebral diffusion-weighted imaging (DWI) within 48 hours (±24 hours) post-procedure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Device Success Rate
時間枠：during the procedure
|
Device success for the balloon dilation catheter is defined as successful delivery, complete inflation, and smooth retrieval of the catheter system.
|
during the procedure
|
|
Incidence of Major Adverse Events (MAE) within 30 days, including any stroke, death, and myocardial infarction.
時間枠：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.
時間枠：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.
時間枠：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.
|
30 days and 90 days post-procedure
|
|
Incidence of transient ischemic attacks (TIA) at 30 days and 90 days post-procedure.
時間枠：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.
|
30 days and 90 days post-procedure
|
|
Incidence of Procedure-related complications (e.g., vessel dissection, hyperperfusion syndrome, etc.).
時間枠：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
|
|
Incidence of adverse events and serious adverse events at 30 days and 90 days post-procedure.
時間枠：30 days and 90 days post-procedure
|
The Incidence of Adverse events or severe adverse event at 30 days and 90 days post-procedure.
|
30 days and 90 days post-procedure
|
|
Incidence of symptomatic intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
時間枠：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.
|
within 48 hours (±24 hours) post-procedure
|
|
Incidence of intracranial hemorrhage within 48 hours (±24 hours) post-procedure.
時間枠：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.
時間枠：90 days post-procedure
|
Incidence of death from any cause occurring within 90 days following the procedure.
|
90 days post-procedure
|
|
Incidence of device defects.
時間枠：during the procedure
|
The Incidence of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
|
during the procedure
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Guodong Xu、Hebei General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2027年6月30日
試験登録日
最初に提出
2026年6月25日
QC基準を満たした最初の提出物
2026年6月25日
最初の投稿 (実際)
2026年7月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月1日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。