Single-Arm Trial of Carotid Stenting for Carotid Stenosis (Timing Trial)
A Prospective, Multicenter, Single-arm, Target Value Clinical Trial to Evaluate the Efficacy and Safety of the Carotid Artery Stent System in the Treatment of Carotid Artery Stenosis
This is a prospective, multicenter, single-group, target value clinical trial planning to enroll 208 eligible subjects. Participants will be treated with the investigational carotid artery stent system and followed up at discharge, 30 days, 6 months, and 12 months postoperatively to evaluate the safety and efficacy of the device for endovascular treatment of carotid artery stenosis.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Liqun Jiao
- 電話番号：010-83198277
- メール：13911224991@139.com
研究場所
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Beijing、中国
- Xuanwu Hospital
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コンタクト：
- Liqun Jiao
- 電話番号：010-83198277
- メール：13911224991@139.com
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
General Inclusion Criteria (all must be satisfied):
- Age ≥18 years, either sex.
- Preoperative carotid duplex ultrasound (DUS) confirms stenosis of the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation, and the subject is deemed suitable for endovascular intervention.
- Intraoperative digital subtraction angiography (DSA) confirms symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥80% (measured by NASCET criteria). Symptomatic is defined as a non-disabling ischemic stroke or transient ischemic attack (TIA), including cerebral hemisphere events or amaurosis fugax, occurring within 6 months prior to the procedure.
- Reference vessel diameter at the target lesion ranges from 3.5 mm to 9.5 mm.
- Voluntarily participates in this trial and signs the informed consent form.
CEA High-Risk Inclusion Criteria (at least one criterion must be met):
Clinical High-Risk Factors:
- Age >80 years.
- Low cardiac output [left ventricular ejection fraction (LVEF) <30%].
- Untreated or poorly controlled arrhythmia (recurrent despite standard medical therapy or other treatment).
- Cardiac insufficiency (New York Heart Association Class III-IV).
- Recent myocardial infarction (occurring between 72 hours and 30 days prior to the procedure).
- Unstable angina (Canadian Cardiovascular Society Class 3-4).
- Severe chronic obstructive pulmonary disease (COPD), defined as forced expiratory volume in 1 second (FEV1) <50% of predicted value.
Anatomic High-Risk Factors:
- Restenosis after prior carotid endarterectomy (CEA).
- Contralateral carotid artery occlusion.
- Tandem carotid artery lesions.
- Carotid artery dissection.
- Pseudoaneurysm.
Exclusion Criteria:
- Target lesion caused by carotid arteritis.
- Target lesion located at the ostium of the common carotid artery.
- Severe, long-segment calcification or severe tortuosity at the target lesion preventing adequate stent delivery.
- Target lesion is a complete occlusion.
- Presence of large acute or subacute thrombus, or arteriovenous malformation adjacent to the target lesion.
- Requirement for concurrent stenting or stenting in other territories (intracranial or extracranial) within 30 days after the procedure.
- Intracranial hemorrhage within 3 months prior to the procedure.
- Large-scale ischemic stroke within 30 days prior to the procedure.
- Known intracranial aneurysm that cannot be treated in advance.
- Known coagulation disorder (activated partial thromboplastin time [APTT] >3 times the upper limit of normal) or abnormal bleeding diathesis.
- Known contraindication to heparin or antiplatelet agents.
- Known allergy to device components, contrast agent, or related materials.
- Severe hepatic or renal insufficiency (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >5 times the upper limit of normal; serum creatinine >3 times the upper limit of normal).
- Uncontrolled severe hypertension (persistent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg).
- Preoperative bradycardia (heart rate <40 beats per minute).
- Preoperative modified Rankin Scale (mRS) score ≥3.
- Malignant tumor with extensive metastasis.
- Currently participating in another drug or device clinical trial.
- Pregnant or lactating women, or women planning pregnancy within 1 year.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this trial.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Carotid Artery Stent System
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All participants will undergo carotid artery stenting (CAS). |
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 |
|---|---|---|
|
Incidence of In-Stent Restenosis (ISR)
時間枠：through study completion, an average of 1 year
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Restenosis is defined as ≥50% diameter stenosis occurring within the stent or within 5 mm of the proximal or distal stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS). |
through study completion, an average of 1 year
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|
Incidence of Major Adverse Events (MAE)
時間枠：through study completion, an average of 1 year
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Major adverse events (MAE) are defined as the composite incidence of: (1) death, stroke (ischemic or hemorrhagic), or myocardial infarction (MI) occurring within 30 days after the procedure; and (2) death or ipsilateral ischemic stroke of the target vessel occurring from 31 to 365 days after the procedure. |
through study completion, an average of 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Device Success Rate
時間枠：Intraoperative
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Defined as the percentage of enrolled subjects in whom device success is achieved. Device success is defined as successful implantation (including delivery, deployment, and expansion) of the stent covering the target lesion, with successful retrieval of the delivery system. |
Intraoperative
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Procedural Success Rate
時間枠：Perioperative
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Defined as the percentage of enrolled subjects in whom procedural success is achieved. Procedural success is defined as successful implantation of the stent, with post-procedure angiography demonstrating ≤30% residual stenosis at the target lesion, and freedom from major adverse events (MAE; defined as all-cause death, stroke, or myocardial infarction) prior to hospital discharge. |
Perioperative
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Incidence of In-Stent Restenosis (ISR)
時間枠：6 months
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Defined as the percentage of enrolled subjects who develop ISR at 6 months post-procedure. ISR is defined as restenosis within the stent or within 5 mm proximal or distal to the stent edge of the target carotid artery, as assessed by carotid duplex ultrasound (DUS), with DUS criteria indicating ≥50% diameter stenosis. |
6 months
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Incidence of Target Lesion Revascularization (TLR)
時間枠：30 days,6 months,12 months
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The percentage of enrolled subjects who undergo TLR within 30 days, at 6 months, and at 12 months post-procedure. TLR is defined as any repeat revascularization (including any surgical or percutaneous intervention) of the target lesion after the initial index procedure. |
30 days,6 months,12 months
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Incidence of Ipsilateral Ischemic Stroke
時間枠：6 months,12 months
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Defined as the percentage of enrolled subjects who experience an ipsilateral ischemic stroke at 6 months and 12 months post-procedure. Ipsilateral ischemic stroke is defined as an ischemic stroke occurring in the cerebral hemisphere supplied by the target vessel (the carotid artery treated during the index procedure). |
6 months,12 months
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：through study completion, an average of 1 year
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through study completion, an average of 1 year
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Incidence of Device Deficiencies
時間枠：through study completion, an average of 1 year
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through study completion, an average of 1 year
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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