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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03993340
Other study ID # 4-2018-1148
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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