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Not Yet RecruitingNCT07495969

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
286 (estimated)
Sponsor
Feng Gao · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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 years), time from the last ischemic event to randomization (14-30 days vs 30-90 days), and occlusion site (anterior circulation vs posterior circulation). The primary endpoint is a composite of 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndovascular Recanalization StrategyBalloon angioplasty and/or stenting;Combined with aggressive medical management.
DRUGAggressive Medical Management100 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.

Timeline

Start date
2026-04-01
Primary completion
2027-12-31
Completion
2028-12-31
First posted
2026-03-27
Last updated
2026-03-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07495969. Inclusion in this directory is not an endorsement.