StrokeIS-EVTNCT03909438
Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke Ischemic Stroke
An observational study of Stroke and Endovascular Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Endovascular Therapy
- What is being tested?
- Endovascular Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy.
Who may be able to join
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- ICA or MCA-M1 or MCA-M2 occlusion as evidenced by MRA or 4D-CTA
- Ethrombectomy can be initiated (femoral puncture) within 6 hours after onset or between 6 and 24 hours after time last know well if conform to the imaging inclusion criteria: Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is ≥ 1.8, penumbra volume is ≥ 15 ml.
Who cannot join
- Large area cerebral infarction of anterior circulation on early CT image (more than 1/3 of cerebral hemisphere)
- Blood glucose <2.7mmol/L or >22.2mmol/L
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Pregnant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
MIN LOU, Ph.D., 8657187784811, loumingxc@vip.sina.com
MIN LOU, Ph.D.
About this study
Official title: Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke
This study aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China.
Read the detailed description
Study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. A database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, National Institute of Health Stroke Scale (NIHSS) score before treatment.
Indications for endovascular therapy refer to the current guidelines. All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. The effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed.
This study will enroll up at least 1,000 patients in 70 centers in China. The primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.
- Conditions
- Stroke, Endovascular Therapy
- Being tested
- Endovascular Thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular ThrombectomyProcedure or surgery
Endovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Good Functional Independence
This outcome will look at the proportion of patients with mRS 0-2 at day 90.
Measured: 90 days
Hemorrhage transformation
hemorrhage transformation at 24-hour after reperfusion therapy:
- Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct;
- Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect;
- Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space- occupying effect; and
- Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space- occupying effect.
- Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan.
Measured: 24-hour
Secondary outcomes (2)
Poor outcome
This outcome will look at the proportion of patients with mRS 3-6 at day 90.
Measured: 90 days
The incidence of recurrent stroke or other vascular events
The incidence of recurrent stroke and other vascular events at 90 days after endovascular therapy.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Sep 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Taizhou Hospital, Lishui Country People's Hospital, The Central Hospital of Lishui City, Shaoxing People's Hospital, Ganzhou City People's Hospital, Luoyang Central Hospital, Huizhou Municipal Central Hospital, The Second Affiliated Hospital of Jiaxing University, Shanghai Zhongshan Hospital, The First People's Hospital of Huzhou, Taizhou First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Min Lou, Ph.D, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909438
- Sponsor's protocol ID
- IS-EVT
- Acronym
- IS-EVT
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Study on the Status of Endovascular Therapy in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03909438
- Acronym / sponsor ID
- IS-EVT / IS-EVT
- Conditions
- Stroke, Endovascular Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Taizhou Hospital, Lishui Country People's Hospital, The Central Hospital of Lishui City, Shaoxing People's Hospital, Ganzhou City People's Hospital, Luoyang Central Hospital, Huizhou Municipal Central Hospital, The Second Affiliated Hospital of Jiaxing University, Shanghai Zhongshan Hospital, The First People's Hospital of Huzhou, Taizhou First People's Hospital
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Apr 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 aims to build a database for patients with acute ischemic stroke who receive endovascular therapy and analyze the current situation, effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke in China.
Detailed description
Study design is a registry, prospective, multicenter study of acute ischemic stroke patients with endovascular treatment. A database will be established including age, gender, smoking history, blood pressure, blood glucose, previous history (such as coronary heart disease, atrial fibrillation, hypertension, diabetes, stroke history, etc.), history of antiplatelet drugs, onset to treatment time, National Institute of Health Stroke Scale (NIHSS) score before treatment.
Indications for endovascular therapy refer to the current guidelines. All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy. The effectiveness, safety and cost-effectiveness of endovascular therapy for acute ischemic stroke will be analyzed.
This study will enroll up at least 1,000 patients in 70 centers in China. The primary end point are proportion of patients with good prognosis after 90 days and intracranial hemorrhage transformation type after 24 hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will receive endovascular therapy, including direct endovascular therapy or intravenous thrombolysis with endovascular therapy.
Key inclusion criteria (5 listed)
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- ICA or MCA-M1 or MCA-M2 occlusion as evidenced by MRA or 4D-CTA
- Ethrombectomy can be initiated (femoral puncture) within 6 hours after onset or between 6 and 24 hours after time last know well if conform to the imaging inclusion criteria: Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is ≥ 1.8, penumbra volume is ≥ 15 ml.
Key exclusion criteria (4 listed)
- Large area cerebral infarction of anterior circulation on early CT image (more than 1/3 of cerebral hemisphere)
- Blood glucose <2.7mmol/L or >22.2mmol/L
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Pregnant
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 ThrombectomyEndovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device | Procedure or surgery | – |
Primary outcome
Good Functional Independence
Time frame: 90 days
This outcome will look at the proportion of patients with mRS 0-2 at day 90.
Hemorrhage transformation
Time frame: 24-hour
hemorrhage transformation at 24-hour after reperfusion therapy: * Hemorrhagic infarction 1 (HI1) was defined as small petechiae along the margins of the infarct; * Hemorrhagic infarction 2 (HI2) as confluent petechiae within the infarcted area but no space-occupying effect; * Parenchymal hemorrhage (PH1) as blood clots in 30% or less of the infarcted area with some slight space- occupying effect; and * Parenchymal hemorrhage (PH2) as blood clots in more than 30% of the infarcted area with substantial space- occupying effect. * Symptomatic intracranial hemorrhage was defined as blood at any site in the brain on the CT scan.
2 secondary outcomes
Poor outcome
Time frame: 90 days
The incidence of recurrent stroke or other vascular events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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. This study is not recruiting at the moment.
Min Lou, Ph.D study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Endovascular Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 inclusion and 4 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 13 Apr 2023. 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 Min Lou, Ph.D (13958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good Functional Independence (time frame: 90 days). The study lists 2 primary outcomes in all. 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 13 Apr 2023.