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

Yonsei University78 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Ischemic Stroke Intracranial Artery Occlusion

Interventions

Rescue stentingDEVICE

The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, modern endovascular thrombectomy using a stent retriever, contact aspiration thrombectomy, or both are allowed. The number of thrombectomy attempts is at the operator's discretion. After failure of standard thrombectomy procedure, rescue stenting with Solitaire will be done. Additional balloon angioplasty, glycoprotein IIb/IIIa inhibitor (GPI), or thrombolytic infusions are optional and at the operator's discretion. After successful recanalization with rescue stenting, intravenous maintenance of GPI at least for a 12 hours and then changed to oral antiplatelet are recommended.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Severance Hospital Stroke Center, Yonsei University College of Medicine

Seoul, Yeonsei-ro Seodaemun-gu, South Korea

Outcomes

Primary Outcomes

modified Rankin scale

The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2

Time frame: 3 months

Secondary Outcomes

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)

Time frame: 1 day to 28 days

Data from ClinicalTrials.gov

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