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Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Observational Study

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

This multicenter, prospective, observational diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment. The study aims to determine whether impaired cerebral autoregulation during thrombectomy can serve as an ultra-early biomarker for predicting futile recanalization in patients with acute ischemic stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18

• Clinical signs consistent with acute ischemic stroke with large vessel occlusion in the anterior circulation (intracranial segment of the internal carotid artery, middle cerebral artery M1 segment) demonstrated with CTA/MRA/DSA.

• NIHSS score ≥ 6 obtained prior to endovascular treatment.

• Modified Rankin Scale ≤ 1 prior to qualifying stroke.

• Acute ischemic stroke, undergone endovascular treatment within 24 hours of onset (time of stroke is the last known normal for wake-up stroke or with unknown onset time).with reaching the goal of mTICI grade 2b-3

• For patients with symptom onset within 6 hours: ASPECTS ≥ 3; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.

• Patient/Legally Authorized Representative has signed the Informed Consent Form.

Locations
Other Locations
China
Beijing Shijitan Hospital, Capital Medical University
RECRUITING
Beijing
Dalian Municipal Central Hospital
NOT_YET_RECRUITING
Dalian
The First Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Weifang People's Hospital Affiliated to Weifang Medical University
RECRUITING
Weifang
Contact Information
Primary
Zidong Li
walx592815088@163.com
010-63925615
Backup
Shen Li
lishen@mail.ccmu.edu.cn
010-63925616
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2026-10-20
Participants
Target number of participants: 129
Treatments
Cerebral autoregulation monitoring cohort
The consecutively enrolled participants undergoing thrombectomy for acute ischemic stroke. Intraoperative cerebral autoregulation will be assessed using near-infrared spectroscopy (NIRS)-based cerebral oxygen saturation monitoring combined with continuous blood pressure monitoring (noninvasive or invasive). This cohort will be used to develop the predictive and validate model for futile recanalization.
Related Therapeutic Areas
Sponsors
Leads: Beijing Shijitan Hospital, Capital Medical University

This content was sourced from clinicaltrials.gov