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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Clinical Inclusion Criteria:

• 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

⁃ Imaging Inclusion Criteria:

• 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 )

Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
MIN LOU, Ph.D.
loumingxc@vip.sina.com
8657187784811
Time Frame
Start Date: 2018-08-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 55
Treatments
Experimental: Endovascular Thrombectomy
Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov