StrokeRESTORENCT05311605
REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
An observational study of Stroke and Vascular Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Vascular Occlusion, Endovascular Treatment
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 31 Dec 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: ischemic stroke patients that received mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset and had perfusion imaging both before and after thrombectomy.
Who may be able to join
- Older than 18 years;
- Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
- Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
- Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
- mRS score ≤2 before admission
- Informed consent obtained for longitudinal enrolled patients, waived of consent for retrospectively included cases
Who cannot join
- Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
- Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
- Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
- Already participated in other drug trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yunyun Xiong
Beijing
Yunyun Xiong, xiongyunyun@bjtth.org
About this study
The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
Read the detailed description
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.
- Conditions
- Stroke, Vascular Occlusion, Endovascular Treatment, Mechanical Thrombectomy, Perfusion Imaging
- Keywords
- ischemic stroke, vascular occlusion, endovascular treatment, mechanical thrombectomy, perfusion imaging
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable functional outcome
proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
Measured: 3 months from stroke onset
Secondary outcomes (6)
Excellent functional outcome at 90 days
proportion of mRS score 0-1 at 3 months
Measured: 3 months from stroke onset
Ordinal distribution of mRS at 90 days
Number of participants with the ordinal distribution of mRS at 90 days
Measured: 3 months from stroke onset
EQ-5D score at at 90 days
EQ-5D score at 3 months. EuroQol Five Dimensions Questionnaire scale (EQ-5D score) has a minimum value of 0 and maximum value of 100. Lower value indicated worse functional outcome
Measured: 3 months from stroke onset
Neurological improvement at 24 hours
NIHSS score <=1 or improvement of NIHSS score>=4 compared with baseline NIHSS. National Institution Health Stroke Scale (NIHSS) has a minimum value of 0 and maximum value of 45. Higher value indicated worse severity of neurological impairment.
Measured: 24 hours from stroke onset
recanalization post-operation
proportion of eTICI 2b50/2c/3. Thrombectomy is a surgical operation using a retrieve stent or aspiration catheter to remove the thrombus inside an occluded vessel and achieve recanalization.The eTICI is a scale to assess the degree of recanalization. So, once the surgeon thought he completed the thrombectomy, he needed to perform a cerebral angiography to assess the degree of recanalization using eTICI.
Measured: (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .
recanalization at 24 hours
proportion of eTICI 2b50/2c/3
Measured: 24 hours after thrombectomy completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start23 Feb 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- 1,600 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Municipal Science & Technology Commission, Beijing Municipal Administration of Hospitals
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Yunyun Xiong, MD, PhD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311605
- Sponsor's protocol ID
- KY-2022-029-01
- Acronym
- RESTORE
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REperfusion Therapy for Acute Ischemic STrOke Due to Large aRtEry Occlusion
- ClinicalTrials.gov ID
- NCT05311605
- Acronym / sponsor ID
- RESTORE / KY-2022-029-01
- Conditions
- Stroke, Vascular Occlusion, Endovascular Treatment, Mechanical Thrombectomy, Perfusion Imaging
- Keywords
- ischemic stroke, vascular occlusion, endovascular treatment, mechanical thrombectomy, perfusion imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Beijing Municipal Science & Technology Commission, Beijing Municipal Administration of Hospitals
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Apr 2022 (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.
The aim of the study was to establish a clinical and advanced imaging database of acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China, and to investigate the predictors and potential mechanisms of futile recanalization after mechanical thrombectomy.
Detailed description
The time-window of mechanical thrombectomy for ischemic stroke has extended from 4.5 hours to 24 hours based on the results of the DAWN and DEFUSE 3 trials. However, evidence on the effectiveness and safety of mechanical thrombectomy within 24 hours in the real-world is insufficient.
This is a multi-center, prospective, registry cohort study that acute ischemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset in China. A retrospective dataset was also build in these stroke centers for analysis. A total of 1600 patients with advanced imaging data were anticipated to be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ischemic stroke patients that received mechanical thrombectomy due to large vessel occlusion of anterior circulation within 24 hours from stroke onset and had perfusion imaging both before and after thrombectomy.
Key inclusion criteria (6 listed)
- Older than 18 years;
- Perfusion imaging completed including CTA+CTP or MRA+PWI+DWI before thrombectomy
- Large vessel occlusion of cerebral anterior circulation (ICA, MCA-M1 or MCA-M2) confirmed by CTA or MRA, planned to receive or received stenting or aspiration thrombectomy
- Time intervals ≤ 24 hours from stroke onset to groin puncture.(fulfilled the inclusion of DAWN or DEFUSE 3 trial if the time intervals from stroke onset to groin puncture was ≥6 hours)
- mRS score ≤2 before admission
Key exclusion criteria (5 listed)
- Had a history of infective disease, immunity disease, radiotherapy at head or neck, carotid dissection or other carotid disease.
- Unable to receive CT or MR scan due to heart failure, cardiac pacemaker, metal implants or claustrophobia, etc.
- Unable to be injected with contrast agent due to allergy, renal dysfunction, etc.
- Unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)
- Already participated in other drug trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Favorable functional outcome
Time frame: 3 months from stroke onset
proportion of mRS score 0-2 at 3 months. The modified Rankin Scale (mRS) has a minimum value of 0 and maximum value of 6. Higher value indicated worse functional outcome
6 secondary outcomes
Excellent functional outcome at 90 days
Time frame: 3 months from stroke onset
Ordinal distribution of mRS at 90 days
Time frame: 3 months from stroke onset
EQ-5D score at at 90 days
Time frame: 3 months from stroke onset
Neurological improvement at 24 hours
Time frame: 24 hours from stroke onset
recanalization post-operation
Time frame: (Day 0) immediately the surgeon thought the thrombectomy completed and performed a second cerebral angiography .
recanalization at 24 hours
Time frame: 24 hours after thrombectomy completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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.
Yunyun Xiong, MD, PhD principal investigator
Beijing Tiantan Hospital
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 Stroke and Vascular Occlusion, run by Beijing Tiantan Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 21 Mar 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunyun Xiong, MD, PhD (00861059975213, xiongyunyun@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable functional outcome (time frame: 3 months from stroke onset). 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 21 Mar 2024.