Ischemic StrokeORANGENCT05024292
Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment
An observational study of Ischemic Stroke, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites in China.
Trial summary
To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- rapid local ischemic postconditioning (RL-IPostC)
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2022to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.
Who may be able to join
- Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
- Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
- Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
- Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
- The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt
Who cannot join
- Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
- Patients underwent rescue angioplasty or stenting after thrombectomy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200233
Jiangshan Deng, PhD, 02164369181, johnson120@126.com
- Recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian
Wenhuo Chen, MD, +86-596-2082950, doctorwwenhuo@126.com
About this study
Official title: Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy
To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.
Read the detailed description
For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.
- Conditions
- Ischemic Stroke
- Being tested
- rapid local ischemic postconditioning (RL-IPostC)
- Keywords
- acute ischemic stroke, thrombectomy, thrombolysis, outcome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapid local ischemic postconditioning (RL-IPostC)Procedure or surgery
with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation
| Study group | Role | What they receive |
|---|---|---|
| rapid local ischemic postconditioning (RL-IPostC) group | RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation. Receives: Procedure: rapid local ischemic postconditioning (RL-IPostC) | |
| control group | no intervention was provided after successful reperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional independence
mRS 0-2
Measured: 3 month
Secondary outcomes (6)
excellent functional independence
mRS 0-1
Measured: 3 month
early therapeutic response
defined as a decrease in the NIHSS score of ≥10 from baseline or an NIHSS score of 0 or 1
Measured: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5
Mortality
Mortality of 3 month after stoke onset
Measured: 3 month
hemorrhagic transformation
according to European Cooperative Acute Stroke Study II criteria
Measured: 24 hours after treatment
Symptomatic intracerebral hemorrhage (sICH)
an increase of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) according to Heidelberg Bleeding Classification
Measured: 24 hours after treatment
malignant infarction
defined as infarct lesions with significant space-occupying mass effect with over 1/2 affected middle cerebral artery territory with imaging signs of herniation and/or and clinical signs of herniation requiring decompressive hemicraniectomy and/or leading to death due to direct implications of stroke
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jan 2022
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yueqi Zhu, PhD, Study chair, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024292
- Sponsor's protocol ID
- 2021MT
- Acronym
- ORANGE
- Status last verified
- Jul 2023
- First submitted
- 22 Aug 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oriental Research Alliance of Acute Ischemic Stroke Given Endovascular Treatment: Technique Feasibility, Safety and Neuroprotective Effects of in Situ Ischemic Postconditioning in Patients Underwent Successful Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT05024292
- Acronym / sponsor ID
- ORANGE / 2021MT
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, thrombectomy, thrombolysis, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Collaborators
- Zhangzhou Municipal Hospital of Fujian Province
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Aug 2021 (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.
To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.
Detailed description
For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rapid local ischemic postconditioning (RL-IPostC) group | – | Procedure: rapid local ischemic postconditioning (RL-IPostC)RL-IPostC is performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation. |
| control group | – | –no intervention was provided after successful reperfusion |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were treated according to national guidelines for treatment of AIS, including intravenous thrombolysis, if indicated. Thrombectomy were performed according to standard techniques. The method of endovascular therapy was selected at the discretion of treating physicians and could include stent retriever and/or catheter aspiration.
Key inclusion criteria (5 listed)
- Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
- Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
- Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
- Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
- The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt
Key exclusion criteria (2 listed)
- Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
- Patients underwent rescue angioplasty or stenting after thrombectomy
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 |
|---|---|---|
| rapid local ischemic postconditioning (RL-IPostC)with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation | Procedure or surgery | rapid local ischemic postconditioning (RL-IPostC) group |
Primary outcome
functional independence
Time frame: 3 month
mRS 0-2
6 secondary outcomes
excellent functional independence
Time frame: 3 month
early therapeutic response
Time frame: on day 5, 6, or 7 of hospitalization or at discharge if it occurred before day 5
Mortality
Time frame: 3 month
hemorrhagic transformation
Time frame: 24 hours after treatment
Symptomatic intracerebral hemorrhage (sICH)
Time frame: 24 hours after treatment
malignant infarction
Time frame: 24 hours after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Yueqi Zhu, PhD study chair
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 2 sites 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueqi Zhu, PhD (+86-21-18930177565, zhuyueqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional independence (time frame: 3 month). 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 12 Jul 2023.