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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993340
• Other study ID #: 4-2018-1148
• Status: Completed
• Start date: June 24, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: September 2021
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 30, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Intracranial Artery Occlusion
• Ischemia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital Stroke Center, Yonsei University College of Medicine	Seoul	Yeonsei-ro Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin scale	The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2	3 months
Secondary	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