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

ConditionsSymptomatic Non-acute Intracranial Artery Occlusion Ischemic Stroke

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorFeng Gao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Endovascular Recanalization Strategy
Procedure/Surgery
Balloon angioplasty and/or stenting;Combined with aggressive medical management.
Aggressive Medical Management
Drug
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.

Treatment groups

286 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame