EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days
EndovascularTherapy Versus Standard Medical Terapy for Intracranial Large Vessel Occlusion in 24 Hours to 30 Days: A Prospective, Multicenter, Real-world Cohort Trial
This study is a prospective, multicenter, observational cohort study using a real-world study design. The aim of this study is to compare functional and safety outcomes of intravascular recanalization therapy (with COSIS distal stent protection technology strategy as the core) combined with standard drug therapy in improving functional outcomes in patients with intracranial large vessel occlusion in the ultra late window (24 hours-30 days) compared with standard drug therapy alone.
調査の概要
状態
詳細な説明
Patients with ischemic stroke whose onset or last known well (LKW) ranged from 24 hours to 30 days, who were confirmed by imaging to have intracranial large vessel occlusion and may still have brain tissue that can be saved were included. The study did not interfere with the choice of treatment options. Patients received intravascular therapy or standard drug treatment, which was determined by clinicians according to the condition, imaging characteristics and the joint decision of doctors and patients. According to the actual treatment of patients, the intravascular treatment cohort and the standard drug treatment cohort were formed, in which the intravascular treatment was centered on the COSIS distal stent protection strategy. The primary outcome is proportion of patients with functional independence defined as mRS score of 0-2 at 90 days after enrollment.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Xuan Sun, MD
- 電話番号：13810926284
- メール：sxuan@yeah.net
研究場所
-
-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100070
- Beijing Tiantan Hospitall, Capital Medical University
-
コンタクト：
- Xuan Sun, MD
- 電話番号：+8613810926284
- メール：sxuan@yeah.net
-
-
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
サンプリング方法
調査対象母集団
All research centers continuously screened eligible patients according to unified standards. The study did not interfere with the choice of treatment options. Whether the patients received intravascular therapy was determined by clinicians according to the condition, imaging characteristics, treatment risk and the joint decision of doctors and patients.
This is a prospective multicenter observational registry-based cohort study. Endovascular treatment is a routine clinical interventional procedure. The decision whether to perform endovascular treatment is made by treating clinicians, not assigned by study investigators. Investigators only collect real-world clinical data and follow-up outcomes of enrolled participants.
説明
Inclusion Criteria:
- Age≥18 years
- The clinical diagnosis was ischemic stroke, and imaging confirmed the presence of intracranial large vessel occlusion
- The time from LKW or the time of finding symptoms is 24 hours to 72 hours; or more than 72 hours but not more than 30 days, and there are neurological deterioration or fluctuation
- Imaging findings suggest that there may still be salvageable brain tissue, which meets any of the following conditions: perfusion imaging examination shows that the ischemic core volume < 70 ml and the mismatch ratio > 1.2; CTA or DSA showed moderate or good collateral circulation; MRI-DWI showed a significant mismatch between lesion size and clinical symptoms
- The modified Rankin Scale score (mRS) before onset was 0-1
- The subjects themselves or their legal representatives voluntarily participated in the study and signed written informed consent
Exclusion Criteria:
- Large area cerebral infarction or imaging showed obvious space occupying effect, such as ASPECTS<6 points,or brainstem infarction area exceeded 1/3 of the corresponding anatomical area
- Isolated extracranial carotid or vertebral artery occlusion
- Intracranial tumors, arteriovenous malformations or other serious intracranial diseases that may significantly affect the evaluation of the outcome of the study
- Intracranial hemorrhage occurred in the past 3 months
- There is a risk of severe coagulation dysfunction, active bleeding or other high bleeding that cannot be corrected
- Severe liver and kidney function damage, which may affect treatment or follow-up
- Pregnant or lactating women
- The estimated survival time is less than 1 year
- Unable to complete 90-day clinical follow-up or main outcome assessment
- Participating in other interventional clinical trials that may affect the treatment or outcome evaluation of this study
- Other circumstances that the researcher believes are not suitable for participating in this study
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Endovascular Treatment Cohort
Intravascular therapy combined with standard drug therapy, in which the core of intravascular therapy is the cosis distal stent protection strategy. |
The recanalization strategy with COSIS distal stent protection technology as the core was used in endovascular treatment.In addition to thrombus removal, the device mainly uses its distal closed basket structure and stent guide wire to form protection and anchor fulcrum at the distal end of occlusion, so as to assist in balloon dilatation, thrombus removal or stent implantation of complex occlusive lesions, and reduce thrombus escape. |
|
Standard Medical Therapy Cohort
Standard drug therapy alone.It mainly includes antiplatelet therapy or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc. |
Standard drug therapy is implemented in accordance with the current guidelines for the diagnosis and treatment of cerebrovascular diseases and the routine of each center, mainly including antiplatelet or anticoagulation therapy, lipid-lowering therapy, blood pressure and blood glucose management, etc. The drug name, dose, route of administration, frequency of administration and course of treatment are determined by the clinician according to the patient's condition. The study only recorded the actual drug treatment and important adjustments. |
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 |
|---|---|---|
|
The proportion of patients with functional independence defined as mRS score of 0 - 2 at 90 days after enrollment
時間枠：90 days after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
90 days after enrollment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The overall distribution of mRS at 90 days after enrollment
時間枠：90 days after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
90 days after enrollment
|
|
National Institutes of Health Stroke Scale (NIHSS) score 24 hours after treatment
時間枠：24 hours after treatment
|
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
24 hours after treatment
|
|
National Institutes of Health Stroke Scale (NIHSS) score at discharge
時間枠：At discharge
|
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
At discharge
|
|
National Institutes of Health Stroke Scale (NIHSS) score 30 days after enrollment
時間枠：30 days after enrollment
|
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
30 days after enrollment
|
|
National Institutes of Health Stroke Scale (NIHSS) score 90 days after enrollment
時間枠：90 days after enrollment
|
The National Institute of Health Stroke Scale (NIHSS) ranged from 0 to 42, with higher scores indicating greater neurologic deficits. |
90 days after enrollment
|
|
The recurrence rate of stroke within 90 days after enrollment
時間枠：90 days after enrollment
|
The recurrence rate of stroke within 90 days after enrollment. |
90 days after enrollment
|
|
Transient ischemic attack within 90 days after enrollment
時間枠：90 days after enrollment
|
Transient ischemic attack within 90 days after enrollment. |
90 days after enrollment
|
|
All-cause mortality within 90 days after enrollment
時間枠：90 days after enrollment
|
All-cause mortality within 90 days after enrollment. |
90 days after enrollment
|
|
Revascularization of target vessels within 90 days after enrollment
時間枠：90 days after enrollment
|
Revascularization of target vessels within 90 days after enrollment. |
90 days after enrollment
|
|
The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b
時間枠：At the end of the procedure
|
The technical success rate of the intravascular treatment cohort，successful recanalization of the target vessel with residual stenosis <50% and final mTICI grade≥2b. |
At the end of the procedure
|
|
Degree of recanalization in the intravascular treatment cohort
時間枠：At the end of the procedure
|
Degree of recanalization in the intravascular treatment cohort.The mTICI scale evaluates angiographic recanalization after endovascular therapy for acute ischemic stroke. Grades range from 0 (no perfusion) to 3 (complete recanalization). mTICI grade≥2b is defined as successful recanalization. |
At the end of the procedure
|
|
Operation time of intravascular treatment cohort
時間枠：During the procedure
|
Operation time of intravascular treatment cohort. |
During the procedure
|
|
Distribution of mRS scores at 6 months after enrollment
時間枠：6 months after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
6 months after enrollment
|
|
The recurrence rate of stroke at 6 months after enrollment
時間枠：6 months after enrollment
|
The recurrence rate of stroke at 6 months after enrollment. |
6 months after enrollment
|
|
Transient ischemic attack at 6 months after enrollment
時間枠：6 months after enrollment
|
Transient ischemic attack at 6 months after enrollment. |
6 months after enrollment
|
|
All-cause mortality at 6 months after enrollment
時間枠：6 months after enrollment
|
All-cause mortality at 6 months after enrollment. |
6 months after enrollment
|
|
Revascularization of target vessels at 6 months after enrollment
時間枠：6 months after enrollment
|
Revascularization of target vessels at 6 months after enrollment. |
6 months after enrollment
|
|
Distribution of mRS scores at 12 months after enrollment
時間枠：12 months after enrollment
|
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death. |
12 months after enrollment
|
|
The recurrence rate of stroke at 12 months after enrollment
時間枠：12 months after enrollment
|
The recurrence rate of stroke at 12 months after enrollment. |
12 months after enrollment
|
|
Transient ischemic attack at 12 months after enrollment
時間枠：12 months after enrollment
|
Transient ischemic attack at 12 months after enrollment. |
12 months after enrollment
|
|
All-cause mortality at 12 months after enrollment
時間枠：12 months after enrollment
|
All-cause mortality at 12 months after enrollment. |
12 months after enrollment
|
|
Revascularization of target vessels at 12 months after enrollment
時間枠：12 months after enrollment
|
Revascularization of target vessels at 12 months after enrollment. |
12 months after enrollment
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events within 12 months after enrollment
時間枠：12 months after enrollment
|
Adverse events events within 12 months after enrollment. |
12 months after enrollment
|
|
Serious adverse events within 12 months after enrollment
時間枠：12 months after enrollment
|
Serious adverse events within 12 months after enrollment. |
12 months after enrollment
|
|
Symptomatic intracranial hemorrhage within 12 months after enrollment
時間枠：12 months after enrollment
|
Symptomatic intracranial hemorrhage within 12 months after enrollment. |
12 months after enrollment
|
|
Ischemic stroke within 12 months after enrollment
時間枠：12 months after enrollment
|
Ischemic stroke within 12 months after enrollment. |
12 months after enrollment
|
|
Hemorrhagic stroke within 12 months after enrollment
時間枠：12 months after enrollment
|
Hemorrhagic stroke within 12 months after enrollment. |
12 months after enrollment
|
|
All-cause death and other important clinical safety events within 12 months after enrollment
時間枠：12 months after enrollment
|
All-cause death and other important clinical safety events within 12 months after enrollment. |
12 months after enrollment
|
|
Proportion of at least one complication in the intravascular therapy cohort
時間枠：Perioperative
|
The intravascular treatment cohort included perioperative vascular dissection, vascular perforation or rupture, distal embolization, acute occlusion, re-occlusion, cerebral hyperperfusion syndrome and puncture site complications. |
Perioperative
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Xuan Sun, MD、Beijing Tiantan Hospital
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
本研究に関する用語
その他の研究ID番号
- HX-A-2026022
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