Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy

Last updated: November 21, 2022
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Thrombosis

Stroke

Treatment

N/A

Clinical Study ID

NCT03502408
yan2017-150
  • Ages > 18
  • All Genders

Study Summary

This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.

Eligibility Criteria

Inclusion

Inclusion Criteria: Clinical Inclusion Criteria:

  1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
  2. Age ≥18 years
  3. NIHSS ≥ 6
  4. Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hoursafter time last know well
  5. No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 )
  6. Patient/Legally Authorized Representative has signed the Informed Consent form Imaging Inclusion Criteria:
  7. ICA or MCA-M1 or MCA-M2 or BA occlusion (carotid occlusions can be cervical orintracranial with or without tandem MCA lesions) as evidenced by MRA or 4D-CTA
  8. Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70ml, mismatch ratio is >/= 1.2 )

Exclusion

Exclusion Criteria: Clinical Exclusion Criteria:

  1. Other serious, advanced, or terminal illness (investigator judgment) or lifeexpectancy is less than 90 days
  2. Subject with a co-morbid disease or condition that would confound the neurological andfunctional evaluations or compromise survival or ability to complete follow-upassessments
  3. Unable to undergo a contrast brain perfusion scan with either MRI or CT
  4. Pregnant
  5. Known serious sensitivity to radiographic contrast agents
  6. Treated with rtPA >6 hours after time last known well
  7. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency;recent oral anticoagulant therapy with INR > 3 (recent use of one of the new oralanticoagulants is not an exclusion if estimated GFR > 30 ml/min).
  8. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
  9. Current participation in another investigational drug or device treatment study
  10. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  11. Any other condition that, in the opinion of the investigator, precludes anendovascular procedure or poses a significant hazard to the subject if an endovascularprocedure was performed. Neuroimaging Exclusion Criteria:
  12. ASPECTS score <6 on non-contrast CT (if patient is enrolled based on CT perfusioncriteria)
  13. Evidence of intracranial tumor (except small meningioma), acute intracranialhemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
  14. Significant mass effect with midline shift
  15. Evidence of internal carotid artery dissection
  16. Intracranial stent implanted in the same vascular territory, known history of arterialtortuosity, and/or other arterial disease that precludes the safe deployment/removalof the thrombectomy device

Study Design

Total Participants: 55
Study Start date:
August 01, 2018
Estimated Completion Date:
August 01, 2026

Study Description

Study design is a prospective, single-center study of acute ischemic stroke patients with large artery occlusion in 6-24 hours of stroke onset. According to patients or their family members' willing, patients who meet the inclusion criteria will be assigned to endovascular thrombectomy group with approved devices (only the devices listed in this protocol are approved for us) plus standard medical therapy or control group (standard medical therapy alone) after undergoing either CT Perfusion or MR Perfusion studies. Patients who have evidence of an ICA or MCA M1 or M2 or BA occlusion and a Target Mismatch Profile will be enrolled.

The intent of this study is to support thrombectomy beyond the currently labeled 8 hour indicated time limit in wake up, unclear onset, and late presenting ischemic stroke subjects, who currently have no other option besides medical management of their symptoms, with careful selection.

The study will enroll up to 55 patients. The primary endpoint, the modified Rankin Score, will be assessed at 3 months.

Connect with a study center

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.