Acute Ischemic StrokeNCT05864638
Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study
An observational study of Acute Ischemic Stroke and Large Vessel Occlusion, run by Changhai Hospital at 1 site in China.
Trial summary
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
- What is being tested?
- Endovascular treatment
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 Aug 2028
- How long will I take part?
- 90 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All acute ischemic stroke patients receiving endovascular treatment
Who may be able to join
- Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
- The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.
Who cannot join
- 1) No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study （OCIN-AIS-EVT REGISTRY）
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
Read the detailed description
The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.
The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).
- Being tested
- Endovascular treatment
- Medical subject headings
- Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatmentDevice
Endovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment | Not described Receives: Device: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.
Measured: 90days
Secondary outcomes (6)
Dichotomized modified Rankin scale (mRS)
Dichotomized modified Rankin scale (mRS) at 90 days after the procedure (0-1 versus 2-6, 0-2 versus 3-6, 0-3 versus 4-6). The value range 0-6: higher scores mean a worse outcome.
Measured: 90days
NIHSS at 24 hours
National Institutes of Health Stroke Scale (NIHSS) score at 24 hours post- procedure. The value range 0-42: higher scores mean a worse outcome.
Measured: 24 hours post-procedure
NIHSS at 7 days
National Institutes of Health Stroke Scale (NIHSS) score at 7 days post procedure. The value range 0-42: higher scores mean a worse outcome.
Measured: 7 days post procedure
Reperfusion outcome
Immediate target vessel recanalization rate post-procedure: defined as proportion of subjects with extended thrombolysis in cerebral infarction (eTICI) score is 2b to 3 The value range 0-3: higher scores mean a better outcome.
Measured: Immediately post-procedure
Early successful revascularization rate
Early successful revascularization rate of target vessels by bridging therapy
Measured: During procedure
Target vessel recanalization rate
Target vessel recanalization rate at 7 days post-procedure (assessed by CTA or MRA or DSA)
Measured: at 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start10 May 2023
- Primary completion30 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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.
- 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
- 10,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-min Liu, Changhai Hospital
- Investigators
- Jianimin Liu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864638
- Sponsor's protocol ID
- OCIN-AIS-EVT REGISTRY
- Status last verified
- Jan 2025
- First submitted
- 13 Apr 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Ischemic Stroke EndoVascular Therapy: a Multicenter REGISTRY Study （OCIN-AIS-EVT REGISTRY）
- ClinicalTrials.gov ID
- NCT05864638
- Acronym / sponsor ID
- OCIN-AIS-EVT REGISTRY
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 May 2023 (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.
A Multicenter Registry of Endovascular Treatment for Acute Ischemic Stroke.
Detailed description
The OCIN-AIS-EVT REGISTRY is a prospective, multicenter, blinded outcome evaluation, observational trial, and aims to determine the functional outcomes and safety of endovascular treatment for AIS, due to vessel occlusion in anterior and posterior circulation, in routine clinical practice.
The primary endpoint is functional outcome, defined as a shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment | – | Device: Endovascular treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All acute ischemic stroke patients receiving endovascular treatment
Key inclusion criteria (3 listed)
- Acute ischemic stroke caused by anterior or posterior circulation vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA)
- Undergo intravascular therapy (i.e. access to a cath lab and an arterial puncture)
- The patient or his/her legal representative agreed to participate in the study and has signed the informed consent.
Key exclusion criteria (1 listed)
- 1) No exclusion criteria
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 |
|---|---|---|
| Endovascular treatmentEndovascular treatment, such as mechanical thrombectomy with stent, aspiration catheter or stent assisted by intermediate aspiration catheter, as well as combination of mechanical thrombectomy with intra-arterial thrombolysis | Device | Endovascular treatment |
Primary outcome
Functional outcome
Time frame: 90days
Shift (improvement) in scores on the modified Rankin scale (mRS) at 90 days (±7 days). The value range 0-6: higher scores mean a worse outcome.
6 secondary outcomes
Dichotomized modified Rankin scale (mRS)
Time frame: 90days
NIHSS at 24 hours
Time frame: 24 hours post-procedure
NIHSS at 7 days
Time frame: 7 days post procedure
Reperfusion outcome
Time frame: Immediately post-procedure
Early successful revascularization rate
Time frame: During procedure
Target vessel recanalization rate
Time frame: at 7 days post-procedure
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 27 Jan 2025.
- Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
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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.
Jianimin Liu, M.D. principal investigator
Changhai 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 Acute Ischemic Stroke and Large Vessel Occlusion, run by Changhai 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 3 inclusion and 1 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 27 Jan 2025. 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?
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 Pengfei Yang, M.D. (86-21-31161784, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 90days). 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 27 Jan 2025.