رادار التجارب AI | ||
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حالة التجربة السريرية NCT07495969 لـ Symptomatic Non-acute Intracranial Artery Occlusion، سكتة دماغية إقفارية هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR） ٢٨٦ عشوائية تجربة مفتوحة
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07495969 هي دراسة تدخُّلية لـSymptomatic Non-acute Intracranial Artery Occlusion، سكتة دماغية إقفارية وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٣ شوال ١٤٤٧ هـ لتجنيد ٢٨٦ مشاركًا. يقودها Feng Gao، ومن المتوقع اكتمالها بحلول ١٥ شعبان ١٤٥٠ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
A multicenter, randomized, open-label, endpoint-blinded trial to compare the effects of endovascular recanalization plus aggressive medical management with aggressive medical management alone on stroke recurrence and mortality in patients with symptomatic non-acute intracranial artery occlusion.
وصف مفصل
This is a multicenter, randomized, open-label, endpoint-blinded trial comparing endovascular recanalization (ER) plus aggressive medical management (AMM) with aggressive medical management alone in patients with symptomatic non-acute intracranial artery occlusion. Randomization will be performed using a central interactive web response system (IWRS) with a 1:1 minimization method, stratified by age (<65 years vs ≥65...عرض المزيد
العنوان الرسمي
Endovascular Recanalization Versus Aggressive Medical Management Alone for Symptomatic Non-Acute Intracranial Artery Occlusion: A Multicenter, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial
الحالات الطبية
Symptomatic Non-acute Intracranial Artery Occlusionسكتة دماغية إقفاريةمعرّفات دراسة أخرى
- HX-A-2025124
NCT معرّف
تاريخ البدء (فعلي)
2026-04-01
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2028-12-31
عدد المشاركين المخطط لهم
٢٨٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
Endovascular Recanalization
Symptomatic Non-acute intracranial artery occlusion
Symptomatic Non-acute intracranial artery occlusion
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةIntervention group Endovascular Recanalization Group | Endovascular Recanalization Strategy Balloon angioplasty and/or stenting;Combined with aggressive medical management. |
أخرىControl group Aggressive Medical Management Group | Aggressive Medical Management 100 mg aspirin per day throughout the follow-up period and 75 mg clopidogrel per day (or ticagrelor or cilostazol) for the initial 90 days after randomization;Cerebrovascular risk factor management. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization | Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization. | Within 1 year after randomization |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
All cause mortality within 1 year after randomization | All cause mortality within 1 year after randomization. | Within 1 year after randomization |
Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization | Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization. | Within 1 year after randomization |
Disabling stroke within 1 year after randomization, defined as any of the following | Disabling stroke within 1 year after randomization, defined as any of the following: ① modified Rankin Scale (mRS) score ≥3; ② an increase of ≥1 in the mRS score from baseline after stroke; ③ National Institutes of Health Stroke Scale (NIHSS) total score ≥7; ④ an increase of ≥4 in the NIHSS score from baseline after stroke. | Within 1 year after randomization |
TIA in the same region as the qualifying artery within 1 year after randomization | TIA in the same region as the qualifying artery within 1 year after randomization. | Within 1 year after randomization |
Unplanned revascularization (extracranial intracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization | Unplanned revascularization (extracranialintracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization. | Within 1 year after randomization |
Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction | Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction. | Within 1 year after randomization |
A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization | A quality-of-life measure (EuroQol five dimensions \[EQ-5D\] scale questionnaire) at 1 year after randomization. | Within 1 year after randomization |
mRS score at 1 year after randomization | mRS score at 1 year after randomization. | Within 1 year after randomization |
Re occlusion rate at 1 year after randomization | Re occlusion rate at 1 year after randomization. | Within 1 year after randomization |
Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications | Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications: in-stent thrombosis; distal embolism; symptomatic intracranial hemorrhage; parenchymal hematoma type 2 (as defined by the Heidelberg classification); arterial dissection; and vessel perforation. | At the end of the operation or intraoperative |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Age ranging between 18 and 80 years.
- Ischemic events (TIA or ischemic stroke) related to the occluded artery, occurring despite aggressive medical management, with the last event occurring within between 14 and 90 days prior to enrollment.
- The modified Rankin Scale (mRS) score 0-2 at the time of enrollment.
- At least one risk factor for atherosclerosis.
- All enrolled patients refused bypass surgery.
- Signatured informed consent form.
Imaging inclusion criteria:
- Occlusion of intracranial ICA, M1 segment of MCA, intracranial VA (with contralateral VA hypoplasia or occlusion), or BA, as confirmed by CT angiography (CTA) or digital subtraction angiography (DSA), and the length of the cclusion segment was≤15mm.
- A decrease of >30% in cerebral blood flow in the territory distal to the target region, as assessed by CT perfusion (CTP); or inadequate collateral compensation indicated by digital subtraction angiography (DSA), defined as an ASITN/SIR collateral grade of 0-2; or evidence of hemodynamic ischemic lesions on CT or MRI.
- Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 for anterior circulation occlusion, or posterior circulation ASPECTS (pc-ASPECTS) ≥ 6 and pons-midbrain index (PMI) < 3 for posterior circulation occlusion, as demonstrated by CT or MRI.
- Technical feasibility of endovascular recanalization (ER) in the qualifying artery evaluated by two experienced interventional neuroradiologists.
- Severe stenosis (70%-99%) or occlusion of other arteries, or tandem stenosis (70%-99%) that is proximal to the qualifying artery.
- Intracranial hemorrhagic diseases such as definite Intracranial tumors, any intracranial vascular malformations, hemorrhagic transformation of infarction, spontaneous intracranial hemorrhage (cerebral parenchymal, subarachnoid, subdural, or epidural) within 30 days.
- Non atherosclerotic intracranial artery disease: arterial dissection, moyamoya disease or moyamoya syndrome demonstrated by imaging examination, or a definite medical history of autoimmune vasculitis.
- Evidence of cardioembolic embolism such as atrial fibrillation, prosthetic valve(s), infective endocarditis, mitral stenosis, atrial myxoma, intracardiac clot or vegetation, left ventricular aneurysms, etc.
- Known unstable angina or myocardial infarction within the last 6 months.
- Intolerance or allergic reaction to any treatment-related medication, including aspirin, clopidogrel, heparin, and local or general anesthetics.
- History of life-threatening allergy to contrast dye.
- Severe liver impairment (AST or ALT > 3 times normal, cirrhosis), serum creatinine > 3.0 mg/dl.
- Past history of EC-IC bypass surgery or EVT.
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment.
- Late-stage malignant tumors, cachexia, or other serious diseases and an expected life expectancy of less than 1 year.
- Pregnant, perinatal stage or lactating women.
- Any other condition (in the opinion of the site investigator) that inappropriate to participate this study.
Feng Gaoالجهة المسؤولة عن الدراسة
Feng Gao, الراعي-المحقق, Vice-Director of Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital
جهة اتصال مركزية للدراسة
جهة اتصال: Feng Gao, MD, 13581936066, [email protected]
1 مواقع الدراسة في 1 بلدان
Beijing Municipality
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, 100070, China