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

NCT03993340 | Completed

• 1 other identifier: 4-2018-1148
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• modified Rankin scale

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

  3 months

Secondary Outcomes (1)

• Patency of the target artery

  1 day to 28 days

Study Arms (1)

1

Rescue stenting group

Device: Rescue stenting

Interventions

Rescue stenting 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.

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
• \. Age 19 or greater
• \. mRS before qualifying stroke, 0 or 1
• \. Baseline NIHSS score 4 or more
• \. CT ASPECTS \> 6 or MR ASPECTS \> 5
• \. 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.
• \. Onset (last-seen-well) time to femoral puncture time \< 24 hours
• \. Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
• \. Subjects who received rescue stenting after failure of mechanical thrombectomy
• \. Anticipated life expectancy of at least 12 months
• \. Signed informed consent for study enrollment

You may not qualify if:

• \. Any contraindication to antiplatelet medication
• \. Multiple simultaneous large vessel occlusions
• \. Pregnancy
• \. Severe contrast allergy or absolute contraindication to iodinated contrast agent
• \. 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital Stroke Center, Yonsei University College of Medicine

Seoul, Yeonsei-ro Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 20, 2019
• Study Start: June 24, 2019
• Primary Completion: July 5, 2021
• Study Completion: July 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)