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

NCT ID: NCT03993340

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2021-07-30

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.

Conditions

Acute Ischemic Stroke; Intracranial Artery Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Rescue stenting group

Rescue stenting

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance Hospital Stroke Center, Yonsei University College of Medicine

Seoul, Yeonsei-ro Seodaemun-gu, South Korea

Countries

South Korea

Other Identifiers

4-2018-1148

Identifier Type: -

Identifier Source: org_study_id