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임상시험 NCT07495969은(는) Symptomatic Non-acute Intracranial Artery Occlusion, 허혈성 뇌졸중에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR） 286 무작위 배정 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07495969은(는) Symptomatic Non-acute Intracranial Artery Occlusion, 허혈성 뇌졸중에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 286명의 참여자를 모집할 예정입니다. Feng Gao이(가) 진행하는 이 연구는 2028년 12월 31일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...더 보기
공식 제목
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
질환명
Symptomatic Non-acute Intracranial Artery Occlusion허혈성 뇌졸중기타 연구 식별자
- HX-A-2025124
NCT 번호
실제 연구 시작일
2026-04-01
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2028-12-31
계획된 등록 인원
286
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Endovascular Recanalization
Symptomatic Non-acute intracranial artery occlusion
Symptomatic Non-acute intracranial artery occlusion
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Intervention group Endovascular Recanalization Group | Endovascular Recanalization Strategy Balloon angioplasty and/or stenting;Combined with aggressive medical management. |
기타Control 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. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- 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 Gao연구 책임자
Feng Gao, 의뢰자-연구자, Vice-Director of Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital
연구 대표 연락처
연락처: Feng Gao, MD, 13581936066, [email protected]
1 1개국에 임상시험 장소
Beijing Municipality
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, 100070, China