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

Completed

• Conditions: Intracranial Artery Occlusion; Acute Ischemic Stroke
• Interventions: Device: Rescue stenting

• Registration Number: NCT03993340
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2019-06-24
• Primary Completion: 2021-07-05
• Study Completion: 2021-07-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Rescue stenting	Rescue stenting group

Primary Outcome Measures

Name	Time	Method
modified Rankin scale	3 months	The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2

Secondary Outcome Measures

Name	Time	Method
Patency of the target artery	1 day to 28 days	The rate of patency of the treated artery at follow-up vascular imaging (magnetic resonance angiography, computed tomography angiography, or catheter angiography)

Trial Locations

Locations (1)

Severance Hospital Stroke Center, Yonsei University College of Medicine; 🇰🇷 Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of