Ischemic StrokePhase 3EASTNCT02350283
Endovascular Therapy for Acute Ischemic Stroke Trial
A Phase 3 study testing Interventional treatment with Solitaire in people with Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 1 site in China.
Trial summary
To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Interventional treatment with Solitaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 3
- 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
Who may be able to join
- Age >18 years
- Clinical diagnosis of ischemic stroke, stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
- No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
- NIHSS ≥ 8 and < 30 at the time of enrollment
- Patient is able to be treated within 12 hours of stroke symptoms onset with minimum of one deployment of the Solitaire Device. (onset time is defined as the last time when the patient was witnessed to be at baseline)
- Patient is confirmed to have symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA/MRA or DSA, at one or more of the following locations: Carotid T/L, M1 MCA, or M2-MCA equivalent affecting at least 50% of MCA territory.
- Patient or patient's legally authorized representative received information about data collection or if mandatory, has signed and dated an Informed Consent Form.
Who cannot join
- Baseline non-contrast CT or DWI reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-6 in the territory of symptomatic intracranial occlusion or DWI lesion volume > 50ml.
- Other confirmation of a moderate to large core defined as one of three ways:
- On a single phase, multiphase or dynamic CTA: no or minimal collaterals in a region greater than 50% of the MCA territory when compared to pial filling on the contralateral side (multiphase/dynamic CTA preferred) OR.
- On CT perfusion (>8 cm coverage): a low CBV and very low CBF ASPECTS <6 in the symptomatic MCA territory OR.
- On CT perfusion(<8 cm coverage): a region of low CBV and very low CBF >1/3 of the CTP imaged symptomatic MCA territory.
- Groin puncture is not possible within 70 minutes of the end of CTA/MRA acquisition.
Show all 26Show fewer
- Seizure at onset of stroke.
- Prior stroke within the last 3 months.
- Investigators thought the cause of occlusion were not atherosclerosis
- Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.
- Presumed septic embolus or suspicion of bacterial endocarditis.
- Life expectancy of less than 90 days.
- Known history of ICH, SAH, AVM or tumor.
- Known disease with increased bleeding risk during the last 3 months, e.g. severe liver disease, ulcerative gastrointestinal disease, esophageal varices, hepatic failure.
- Major surgery ,significant trauma or hemorrhagic disease in past 10 days
- Uncompensated hypertension defined as systolic blood pressure >185 mm Hg or diastolic blood pressure ≥110 mm Hg on 3 repeated measures at least 10 minutes apart.
- Renal Failure as defined by a serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30.
- Platelet count of below 100,000/mm3.
- Blood glucose <2.8 or >22.2 mmol/l.
- Patients receiving oral anticoagulants, e.g. warfarin sodium, and coagulant response time (INR) >1.5.
- Administration of heparin within the previous 48 hours and APTT time exceeding the upper limit of normal for laboratory.
- Suspected intracranial dissection as a cause of stroke.
- Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
- No femoral pulses.
- Contraindications of DSA examination, severe contrast allergy or absolute contraindication to iodinated contrast.
- Pregnancy; if a woman of child-bearing potential has a positive urine or serum beta HCG test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Control Study to Evaluate of Thrombectomy With Solitaire in Patients With Acute Ischemic Stroke
To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset.
Read the detailed description
This study is a multicenter, prospective, control study. Patients with acute ischemic stroke who meet inclusion criteria would be enrolled in the study. If the patient or patient's legally authorized representative decides that the patient should receive the intervention operation and signs the informed consent of intervention operation, the patient will be assigned to the intervention group. If the patient participates in the EAST study but refuses intervention after notified of all the benefits and risk of intervention and conservative treatment, the patient will be assigned to the control group.There will be 150 patients enrolled in each group. Patients in the intervention group will be treated with mechanical recanalization using Solitaire plus standard medical therapy. Patients in the control group will receive standard medical therapy alone.
All patients were followed up for 90 days upon enrollment. During the trial, multiple indicators will be assessed in all patients at baseline, 24hours,14days (or at discharge, whichever occurs first) and 90 days. Primary efficacy endpoint will be functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or function improvement by mRS shift analysis.Primary procedure efficacy endpoint will be arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device. Primary safety endpoint is systematic ICH with 24 ±3hrs post procedure.The secondary endpoints include: rate of device-related and procedure related Serious Adverse Events (SAEs) at 14 days or discharge; volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure; arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure; infarction in subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage;death due to any cause at 14days or discharge and at 90 days; change in NIHSSat 24±3hrs post procedure;change in NIHSS at 14 days or discharge post procedure; change in NIHSSat 90 ± 7days; quality of life at 90± 7days; the proportion of patients who suffer a Safety Outcome : the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to femoral artery access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy;economic (cost-effectiveness) analysis;evaluation of waiver/deferral of consent process; the total radiation dose (CT, CTA, angiography) reported as a continuous measure;the proportion of patients with malignant MCA infarction;the proportion of patients undergoing hemicraniectomy.
Because a substantial number of patients are expected to have intracranial atherosclerosis, subgroup analysis will also be carried out on this group of patient. The clinical outcomes, the final TICI score after angioplasty and possible stenting, and symptomatic ICH (including SAH) and immediate re-thrombosis rate will be included in the subgroup analysis.
- Conditions
- Ischemic Stroke
- Being tested
- Interventional treatment with Solitaire
- Keywords
- Acute Ischemic Stroke, Endovascular therapy, Solitaire, Standard Medical Management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional treatment with SolitaireDevice
Patients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management.
| Study group | Role | What they receive |
|---|---|---|
| Solitaire Device | Experimental | Interventional treatment with Solitaire. After the procedure, the patients will be admitted to intensive care unit. Standard medical management will be provided to these patients. Receives: Device: Interventional treatment with Solitaire |
| Medical treatment | No intervention | Standard medical treatment alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or by functional improvement as defined by mRS using shift analysis
Measured: 90 days
Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device
Measured: 24hours
Systematic ICH with 24 ±3hrs post procedure
Measured: 24 hours
Secondary outcomes (16)
Rate of device-related and procedure related Serious Adverse Events (SAEs) at 7 days or discharge
Measured: 7days
Volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure
Measured: 24 hours
Arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure
Measured: 24 hours
Infarction in subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage
Measured: 24 hours
Death due to any cause at 14days or discharge and at 90 days
Measured: 90 days
Change in NIHSS at 24±3hrs post procedure
Measured: 24 hours
Change in NIHSS at 14 days or discharge post procedure
Measured: 14 days
Change in NIHSS at 90 ± 7days
Measured: 90 days
Quality of life at at90 ± 7days(EQ-5D,BI)
Measured: 90 days
The proportion of patients who suffer a Safety Outcome
Measured: 90 days
Economic (cost-effectiveness) analysis
Measured: 90 days
Evaluation of waiver/deferral of consent process
Measured: 90 days
The total radiation dose (CT, CTA, angiography) reported as a continuous measure
Measured: 90 days
The proportion of patients with malignant MCA infarction
Measured: 90 days
The proportion of patients undergoing hemicraniectomy
Measured: 90 days
Subgroup analysis of reperfusion in patients with intracranial atherosclerosis
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 posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350283
- Sponsor's protocol ID
- 2011BAE08B02
- Acronym
- EAST
- Status last verified
- Jun 2017
- First submitted
- 15 Jan 2015
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jia B, Feng L, Liebeskind DS, Huo X, Gao F, Ma N, Mo D, Liao X, Wang C, Zhao X, Pan Y, Li H, Liu L, Wang Y, Wang Y, Miao ZR; EAST Study Group. Mechanical thrombectomy and rescue therapy for intracranial large artery occlusion with underlying atherosclerosis. J Neurointerv Surg. 2018 Aug;10(8):746-750. doi: 10.1136/neurintsurg-2017-013489. Epub 2017 Dec 4.
PubMed 29203731Miao Z, Huo X, Gao F, Liao X, Wang C, Peng Y, Cao Y, Chen S, Zhang M, Jiang C, Peng X, Song C, Wei L, Zhu Q, Guo Z, Liu L, Lin H, Yang H, Wu W, Liang H, Xu A, Chen K, Zhao X, Pan Y, Li H, Liu L, Wang Y, Wang Y; EAST investigators. Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China. Stroke Vasc Neurol. 2016 Jun 24;1(2):44-51. doi: 10.1136/svn-2016-000022. eCollection 2016 Jun.
PubMed 28959463
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Control Study to Evaluate of Thrombectomy With Solitaire in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02350283
- Acronym / sponsor ID
- EAST / 2011BAE08B02
- Conditions
- Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Endovascular therapy, Solitaire, Standard Medical Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- Jan 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Jan 2015 (estimated)
- 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 evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset.
Detailed description
This study is a multicenter, prospective, control study. Patients with acute ischemic stroke who meet inclusion criteria would be enrolled in the study. If the patient or patient's legally authorized representative decides that the patient should receive the intervention operation and signs the informed consent of intervention operation, the patient will be assigned to the intervention group. If the patient participates in the EAST study but refuses intervention after notified of all the benefits and risk of intervention and conservative treatment, the patient will be assigned to the control group.There will be 150 patients enrolled in each group. Patients in the intervention group will be treated with mechanical recanalization using Solitaire plus standard medical therapy. Patients in the control group will receive standard medical therapy alone.
All patients were followed up for 90 days upon enrollment. During the trial, multiple indicators will be assessed in all patients at baseline, 24hours,14days (or at discharge, whichever occurs first) and 90 days. Primary efficacy endpoint will be functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or function improvement by mRS shift analysis.Primary procedure efficacy endpoint will be arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device. Primary safety endpoint is systematic ICH with 24 ±3hrs post procedure.The secondary endpoints include: rate of device-related and procedure related Serious Adverse Events (SAEs) at 14 days or discharge; volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure; arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure; infarction in subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage;death due to any cause at 14days or discharge and at 90 days; change in NIHSSat 24±3hrs post procedure;change in NIHSS at 14 days or discharge post procedure; change in NIHSSat 90 ± 7days; quality of life at 90± 7days; the proportion of patients who suffer a Safety Outcome : the proportion of patients with the composite of: (i) symptomatic intracranial hemorrhage (ii) major bleeding due to femoral artery access complications including groin hematoma, retroperitoneal hematoma (iii) contrast nephropathy;economic (cost-effectiveness) analysis;evaluation of waiver/deferral of consent process; the total radiation dose (CT, CTA, angiography) reported as a continuous measure;the proportion of patients with malignant MCA infarction;the proportion of patients undergoing hemicraniectomy.
Because a substantial number of patients are expected to have intracranial atherosclerosis, subgroup analysis will also be carried out on this group of patient. The clinical outcomes, the final TICI score after angioplasty and possible stenting, and symptomatic ICH (including SAH) and immediate re-thrombosis rate will be included in the subgroup analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solitaire Device | Experimental | Device: Interventional treatment with SolitaireInterventional treatment with Solitaire. After the procedure, the patients will be admitted to intensive care unit. Standard medical management will be provided to these patients. |
| Medical treatment | No intervention | –Standard medical treatment alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Clinical diagnosis of ischemic stroke, stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
- No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
- NIHSS ≥ 8 and < 30 at the time of enrollment
- Patient is able to be treated within 12 hours of stroke symptoms onset with minimum of one deployment of the Solitaire Device. (onset time is defined as the last time when the patient was witnessed to be at baseline)
Key exclusion criteria (26 listed)
- Baseline non-contrast CT or DWI reveals a moderate/large core defined as extensive early ischemic changes of ASPECTS 0-6 in the territory of symptomatic intracranial occlusion or DWI lesion volume > 50ml.
- Other confirmation of a moderate to large core defined as one of three ways:
- Groin puncture is not possible within 70 minutes of the end of CTA/MRA acquisition.
- Seizure at onset of stroke.
- Prior stroke within the last 3 months.
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 |
|---|---|---|
| Interventional treatment with SolitairePatients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management. | Device | Solitaire Device |
Primary outcome
Functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or by functional improvement as defined by mRS using shift analysis
Time frame: 90 days
Arterial recanalization of the occluded target vessel measured by Thrombolysis in Cerebral Infarction (TICI) score equal or superior to 2b right following the use of the Study Device
Time frame: 24hours
Systematic ICH with 24 ±3hrs post procedure
Time frame: 24 hours
16 secondary outcomes
Rate of device-related and procedure related Serious Adverse Events (SAEs) at 7 days or discharge
Time frame: 7days
Volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure
Time frame: 24 hours
Arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure
Time frame: 24 hours
Infarction in subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage
Time frame: 24 hours
Death due to any cause at 14days or discharge and at 90 days
Time frame: 90 days
Change in NIHSS at 24±3hrs post procedure
Time frame: 24 hours
Change in NIHSS at 14 days or discharge post procedure
Time frame: 14 days
Change in NIHSS at 90 ± 7days
Time frame: 90 days
Quality of life at at90 ± 7days(EQ-5D,BI)
Time frame: 90 days
The proportion of patients who suffer a Safety Outcome
Time frame: 90 days
Economic (cost-effectiveness) analysis
Time frame: 90 days
Evaluation of waiver/deferral of consent process
Time frame: 90 days
The total radiation dose (CT, CTA, angiography) reported as a continuous measure
Time frame: 90 days
The proportion of patients with malignant MCA infarction
Time frame: 90 days
The proportion of patients undergoing hemicraniectomy
Time frame: 90 days
Subgroup analysis of reperfusion in patients with intracranial atherosclerosis
Time frame: 90 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 21 Jun 2017.
- Derived from this study: PubMed 29203731Jia B, Feng L, Liebeskind DS, Huo X, Gao F, Ma N, Mo D, Liao X, Wang C, Zhao X, Pan Y, Li H, Liu L, Wang Y, Wang Y, Miao ZR; EAST Study Group. Mechanical thrombectomy and rescue therapy for intracranial large artery occlusion with underlying atherosclerosis. J Neurointerv Surg. 2018 Aug;10(8):746-750. doi: 10.1136/neurintsurg-2017-013489. Epub 2017 Dec 4.
- Derived from this study: PubMed 28959463Miao Z, Huo X, Gao F, Liao X, Wang C, Peng Y, Cao Y, Chen S, Zhang M, Jiang C, Peng X, Song C, Wei L, Zhu Q, Guo Z, Liu L, Lin H, Yang H, Wu W, Liang H, Xu A, Chen K, Zhao X, Pan Y, Li H, Liu L, Wang Y, Wang Y; EAST investigators. Endovascular therapy for Acute ischemic Stroke Trial (EAST): study protocol for a prospective, multicentre control trial in China. Stroke Vasc Neurol. 2016 Jun 24;1(2):44-51. doi: 10.1136/svn-2016-000022. eCollection 2016 Jun.
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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?
A Phase 3 study testing Interventional treatment with Solitaire in people with Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China 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 7 inclusion and 26 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 21 Jun 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Functional independence as defined by modified Rankin Scale (mRS) score ≤ 2 at 90 days or by functional improvement as defined by mRS using shift analysis (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350283, which also lists 2 linked publications.
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 Jun 2017.