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Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR） 286 Randomisiert Offene Studie

Noch nicht rekrutierend
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Die klinische Studie NCT07495969 ist eine interventionsstudie zur Untersuchung von Symptomatic Non-acute Intracranial Artery Occlusion, Ischämischer Schlaganfall und hat den Status noch nicht rekrutierend. Der Start ist für 1. April 2026 geplant, bis 286 Teilnehmer aufgenommen werden. Durchgeführt von Feng Gao wird der Abschluss für 31. Dezember 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
Symptomatic Non-acute Intracranial Artery OcclusionIschämischer Schlaganfall
Weitere Studien-IDs
  • HX-A-2025124
NCT-Nummer
NCT07495969
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2028-12-31
Geplante Rekrutierung
286
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Endovascular Recanalization
Symptomatic Non-acute intracranial artery occlusion
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellIntervention group
Endovascular Recanalization Group
Endovascular Recanalization Strategy
Balloon angioplasty and/or stenting;Combined with aggressive medical management.
AndereControl 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.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  1. Age ranging between 18 and 80 years.
  2. 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.
  3. The modified Rankin Scale (mRS) score 0-2 at the time of enrollment.
  4. At least one risk factor for atherosclerosis.
  5. All enrolled patients refused bypass surgery.
  6. Signatured informed consent form.

Imaging inclusion criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Technical feasibility of endovascular recanalization (ER) in the qualifying artery evaluated by two experienced interventional neuroradiologists.

  1. Severe stenosis (70%-99%) or occlusion of other arteries, or tandem stenosis (70%-99%) that is proximal to the qualifying artery.
  2. 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.
  3. Non atherosclerotic intracranial artery disease: arterial dissection, moyamoya disease or moyamoya syndrome demonstrated by imaging examination, or a definite medical history of autoimmune vasculitis.
  4. 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.
  5. Known unstable angina or myocardial infarction within the last 6 months.
  6. Intolerance or allergic reaction to any treatment-related medication, including aspirin, clopidogrel, heparin, and local or general anesthetics.
  7. History of life-threatening allergy to contrast dye.
  8. Severe liver impairment (AST or ALT > 3 times normal, cirrhosis), serum creatinine > 3.0 mg/dl.
  9. Past history of EC-IC bypass surgery or EVT.
  10. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment.
  11. Late-stage malignant tumors, cachexia, or other serious diseases and an expected life expectancy of less than 1 year.
  12. Pregnant, perinatal stage or lactating women.
  13. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study.
Feng Gao logoFeng Gao
Verantwortliche Partei
Feng Gao, Prüfsponsor, Vice-Director of Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital
Zentrale Studienkontakte
Kontakt: Feng Gao, MD, 13581936066, [email protected]
1 Studienstandorte in 1 Ländern

Beijing Municipality

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, 100070, China