Acute Ischemic Stroke Clinical Trial
Official title:
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
NCT number | NCT03993340 |
Other study ID # | 4-2018-1148 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 24, 2019 |
Est. completion date | July 30, 2021 |
Verified date | September 2021 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 78 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - 1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment) - 2. Age 19 or greater - 3. mRS before qualifying stroke, 0 or 1 - 4. Baseline NIHSS score 4 or more - 5. CT ASPECTS > 6 or MR ASPECTS > 5 - 6. 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. - 7. Onset (last-seen-well) time to femoral puncture time < 24 hours - 8. Failure of mechanical thrombectomy with stent retriever, contact aspiration or both - 9. Subjects who received rescue stenting after failure of mechanical thrombectomy - 10. Anticipated life expectancy of at least 12 months - 11. Signed informed consent for study enrollment Exclusion Criteria: - 1. Any contraindication to antiplatelet medication - 2. Multiple simultaneous large vessel occlusions - 3. Pregnancy - 4. Severe contrast allergy or absolute contraindication to iodinated contrast agent - 5. 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Severance Hospital Stroke Center, Yonsei University College of Medicine | Seoul | Yeonsei-ro Seodaemun-gu |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | modified Rankin scale | The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2 | 3 months | |
Secondary | Patency of the target artery | The rate of patency of the treated artery at follow-up vascular imaging (magnetic resonance angiography, computed tomography angiography, or catheter angiography) | 1 day to 28 days |
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