Endovascular Treatment for Acute Large Vessel Occlusion With Ultra-Large Ischemic Core

Sponsor
First Affiliated Hospital of Harbin Medical University
Study ID
NCT07791810
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patients assigned to the EVT group should undergo EVT as soon as possible, followed by BMM according to the current EVT guidelines. — PROCEDURE
    EVT should be performed as soon as possible in patients randomized to the EVT group. Investigators and clinicians should make every effort to minimize delays related to pre-procedural preparation, with a target interval of no more than 60 minutes from randomization to arterial puncture. EVT in the EVT group can be performed with any thrombectomy device (NMPA approved) usually used at study site.
  • The medical group receives BMM alone. EVT is not performed in the medical group. — DRUG
    The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to current AIS management guidelines but may NOT include any intra-arterial therapies.

Study Details

an investigator initiated, prospective, multicenter, randomized, open-label, blinded endpoint trial (PROBE)

Key Dates

First listed
Aug 28, 2026
Start date
Sep 18, 2026
Status verified
Aug 2026
Primary completion
Apr 18, 2028
Completion
Apr 18, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EVT group
  • Active Comparator: Medical group

Primary Outcome Measure

The primary efficacy endpoint is the mRS score at 90 days after randomization. [ Time Frame: at 90 days after randomization. ]

Central Contacts

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