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Endovascular Therapy for Acute Ischemic Stroke Trial (EAST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02350283
First Posted: January 29, 2015
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China
  Purpose
To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset.

Condition Intervention Phase
Ischemic Stroke Device: Interventional treatment with Solitaire Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Control Study to Evaluate of Thrombectomy With Solitaire in Patients With Acute Ischemic Stroke

Further study details as provided by Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 225
Actual Study Start Date: January 2015
Study Completion Date: December 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Solitaire Device
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.
Device: Interventional treatment with Solitaire
Patients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management.
No Intervention: Medical treatment
Standard medical treatment alone.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Clinical diagnosis of ischemic stroke, stroke symptoms present for at least 30 minutes and has not significantly improved before treatment
  3. No pre-stroke functional dependence (pre-stroke Modified Rankin Score ≤ 1)
  4. NIHSS ≥ 8 and < 30 at the time of enrollment
  5. 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)
  6. 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.
  7. Patient or patient's legally authorized representative received information about data collection or if mandatory, has signed and dated an Informed Consent Form.

Exclusion Criteria:

  1. 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.
  2. Other confirmation of a moderate to large core defined as one of three ways:

    i. 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.

    ii. On CT perfusion (>8 cm coverage): a low CBV and very low CBF ASPECTS <6 in the symptomatic MCA territory OR.

    iii. On CT perfusion(<8 cm coverage): a region of low CBV and very low CBF >1/3 of the CTP imaged symptomatic MCA territory.

  3. Groin puncture is not possible within 70 minutes of the end of CTA/MRA acquisition.
  4. Seizure at onset of stroke.
  5. Prior stroke within the last 3 months.
  6. Investigators thought the cause of occlusion were not atherosclerosis
  7. Subject with a pre-existing neurological or psychiatric disease that would confound the neurological and functional evaluations.
  8. Presumed septic embolus or suspicion of bacterial endocarditis.
  9. Life expectancy of less than 90 days.
  10. Known history of ICH, SAH, AVM or tumor.
  11. Known disease with increased bleeding risk during the last 3 months, e.g. severe liver disease, ulcerative gastrointestinal disease, esophageal varices, hepatic failure.
  12. Major surgery ,significant trauma or hemorrhagic disease in past 10 days
  13. 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.
  14. Renal Failure as defined by a serum creatinine > 2.0 or Glomerular Filtration Rate [GFR] < 30.
  15. Platelet count of below 100,000/mm3.
  16. Blood glucose <2.8 or >22.2 mmol/l.
  17. Patients receiving oral anticoagulants, e.g. warfarin sodium, and coagulant response time (INR) >1.5.
  18. Administration of heparin within the previous 48 hours and APTT time exceeding the upper limit of normal for laboratory.
  19. Suspected intracranial dissection as a cause of stroke.
  20. Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  21. No femoral pulses.
  22. Contraindications of DSA examination, severe contrast allergy or absolute contraindication to iodinated contrast.
  23. Pregnancy; if a woman of child-bearing potential has a positive urine or serum beta HCG test.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350283


Locations
China, Beijing
Beijing tiantan Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China
  More Information

Responsible Party: Zhongrong Miao, Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital, Ministry of Science and Technology of the People´s Republic of China
ClinicalTrials.gov Identifier: NCT02350283     History of Changes
Other Study ID Numbers: 2011BAE08B02
First Submitted: January 15, 2015
First Posted: January 29, 2015
Last Update Posted: June 21, 2017
Last Verified: June 2017

Keywords provided by Zhongrong Miao, Ministry of Science and Technology of the People´s Republic of China:
Acute Ischemic Stroke
Endovascular therapy
Solitaire
Standard Medical Management

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia