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

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 Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Intracranial Artery Occlusion
• Intervention / Treatment: Device: Rescue stenting

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeonsei-ro Seodaemun-gu
    • Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722
      • Severance Hospital Stroke Center, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with emergent large vessel occlusion and who have not achieved successful recanalization (defined by mTICI, 2b or 3) by mechanical thrombectomy using stent retriever or aspiration thrombectomy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1; Rescue stenting group

Device: Rescue stenting; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin scale	The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 4-2018-1148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No