Acute Ischemic StrokeNCT03993340
Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
An observational study of Acute Ischemic Stroke and Intracranial Artery Occlusion, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Intracranial Artery Occlusion
- What is being tested?
- Rescue stenting
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jun 2019to 30 Jul 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital Stroke Center, Yonsei University College of Medicine
Seoul, Yeonsei-ro Seodaemun-gu, 03722
About this study
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.
- Being tested
- Rescue stenting
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rescue stentingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Rescue stenting group Receives: Device: Rescue stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale
The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 1 day to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start24 Jun 2019
- Primary completion5 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993340
- Sponsor's protocol ID
- 4-2018-1148
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)
- ClinicalTrials.gov ID
- NCT03993340
- Acronym / sponsor ID
- 4-2018-1148
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Rescue stentingRescue stenting group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rescue stentingThe 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. | Device | 1 |
Primary outcome
modified Rankin scale
Time frame: 3 months
The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2
1 secondary outcome
Patency of the target artery
Time frame: 1 day to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Intracranial Artery Occlusion, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.