- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03993340
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
September 7, 2021 updated by: Yonsei University
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
78
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yeonsei-ro Seodaemun-gu
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Seoul, Yeonsei-ro Seodaemun-gu, Korea, Republic of, 03722
- Severance Hospital Stroke Center, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Rescue stenting group
|
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
Time Frame: 3 months
|
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
Time Frame: 1 day to 28 days
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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