Endovascular Therapy for Acute Ischemic Stroke Trial

NCT02350283 | Completed Phase 3 DMC

• 1 other identifier: 2011BAE08B02
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Solitaire thrombectomy in Chinese patients with acute stroke within 12 hours of symptom onset.

Conditions

Ischemic Stroke

Keywords

Acute Ischemic Stroke; Endovascular therapy; Solitaire; Standard Medical Management

Outcome Measures

Primary Outcomes (3)

• 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

  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

  24hours

• Systematic ICH with 24 ±3hrs post procedure

  24 hours

Secondary Outcomes (16)

• Rate of device-related and procedure related Serious Adverse Events (SAEs) at 7 days or discharge

  7days

• Volume of cerebral infarction as measured by a CT scan at 24 ±3hrs post procedure

  24 hours

• Arterial reperfusion measured by reperfusion ratio on CT scan 24 ±3hrs post procedure

  24 hours

• Infarction in subjects who achieved TICI 2b-3 reperfusion without intracranial hemorrhage

  24 hours

• Death due to any cause at 14days or discharge and at 90 days

  90 days

Study Arms (2)

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.

Device: Interventional treatment with Solitaire

Medical treatment

NO INTERVENTION

Standard medical treatment alone.

Interventions

Interventional treatment with Solitaire DEVICE

Patients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management.

Solitaire Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.
• 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

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead

Study Sites (1)

Beijing tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

• 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.

  PMID: 29203731 DERIVED

• Miao 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.

  PMID: 28959463 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

CN (1)