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Clinical Trials/NCT03993340
NCT03993340
Completed
Not Applicable

Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)

Yonsei University1 site in 1 country78 target enrollmentJune 24, 2019

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2019
End Date
July 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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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