NCT03993340
Completed
Not Applicable
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Yonsei University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- modified Rankin scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (ELVO) patients who have mechanical thrombectomy failure. Participants with ELVO will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. After failure of mechanical thrombectomy, rescue stenting will be performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
- •Age 19 or greater
- •mRS before qualifying stroke, 0 or 1
- •Baseline NIHSS score 4 or more
- •CT ASPECTS \> 6 or MR ASPECTS \> 5
- •Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
- •Onset (last-seen-well) time to femoral puncture time \< 24 hours
- •Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
- •Subjects who received rescue stenting after failure of mechanical thrombectomy
- •Anticipated life expectancy of at least 12 months
Exclusion Criteria
- •Any contraindication to antiplatelet medication
- •Multiple simultaneous large vessel occlusions
- •Severe contrast allergy or absolute contraindication to iodinated contrast agent
- •Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
Outcomes
Primary Outcomes
modified Rankin scale
Time Frame: 3 months
The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2
Secondary Outcomes
- Patency of the target artery(1 day to 28 days)
Study Sites (1)
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