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

NCT03502408 | Recruiting DMC

• 1 other identifier: yan2017-150
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Acute Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Good Functional Independence

  This outcome will look at the proportion of patients with mRS 0-2 at day 90.

  90 days

Secondary Outcomes (2)

• Death

  90 days

• Symptomatic Intracranial Hemorrhage

  24 hours

Study Arms (1)

Endovascular Thrombectomy

EXPERIMENTAL

Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device

Procedure: Endovascular Thrombectomy

Interventions

Endovascular Thrombectomy PROCEDURE

Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device

Endovascular Thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
• Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
• Unable to undergo a contrast brain perfusion scan with either MRI or CT
• Pregnant
• Known serious sensitivity to radiographic contrast agents
• Treated with rtPA \>6 hours after time last known well
• Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
• Current participation in another investigational drug or device treatment study
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
• ASPECTS score \<6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria)
• Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
• Significant mass effect with midline shift
• Evidence of internal carotid artery dissection
• Intracranial stent implanted in the same vascular territory, known history of arterial tortuosity, and/or other arterial disease that precludes the safe deployment/removal of the thrombectomy device

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• MIN LOU, Ph.D.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

MIN LOU, Ph.D.

CONTACT

8657187784811; loumingxc@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 18, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)