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Direct Endovascular Treatment versus Bridging Therapy for Patients with Acute Ischemic Stroke

Multicenter Randomized Trial of Direct endovascular treatment versus bridging therapy for Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within 4.5 Hours of Symptom Onset.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013568
Enrollment
Unknown
Registered
2017-11-27
Start date
2018-05-01
Completion date
Unknown
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute ischemic stroke

Interventions

direct endovascular treatment group:endovascular treatment
bridging therapy group:IV rtPA+endovascular treatment

Sponsors

Xinqiao Hospital, the Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 years or older; 2) Anterior circulation acute ischemic stroke confirmed by clinical symptoms or imaging examination; 3) I-ICA or MCA-M1 occlusion proved by CTA/MRA/DSA; 4) Eligible for intravenous thrombolysis with r-tPA; 5) Time from stroke onset to randomization within 4.25h; 6) Written informed consent is obtained from patients and/or their legal representatives.

Exclusion criteria

Exclusion criteria: 1) Intracranial hemorrhage; 2) Contraindications of IV rt-PA; 3) Pre-stroke disability mRS score >= 2; 4) Pregnancy or lactating women; 5) Known sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys;; 6) Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel; 7) Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 8) Subjects with occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); 9) CT or MRI evidence of mass effect or intracranial tumor (except small meningioma); 10) CT or MRI evidence of cerebral vasculitis; 11) CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms; 12) Any terminal illness with life expectancy less than 6 months; 13) Unlikely to be available for 90-day follow-up; 14) Current participation in another clinical trial.

Design outcomes

Primary

MeasureTime frame
mRS score 0–1 vs. 2-6 at 90 days;Symptomatic intracerebral hemorrhage rate within 48 h;Mortality rate at 90 days;

Secondary

MeasureTime frame
mRS score 0–1 vs. 2-6 at 90 days;Shift in the distribution of mRS scores at 90 days in treatment versus controls;Vessel recanalization rate evaluated by CTA or MRA within 48h;NIHSS score at 24 h;NIHSS score at 5–7 days;EQ-5D at 90 days;Successful recanalization proportion immediate after EVT;

Countries

China

Contacts

Public ContactQingwu Yang

Xinqiao Hospital, the Third Military Medical University

yangqwmlys@163.com+86 13657638868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026