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Emergent Microsurgical Intervention in Acute Stroke Patients After Mechanical Thrombectomy Failure Trial (EMIAS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05153642
Recruitment Status : Recruiting
First Posted : December 10, 2021
Last Update Posted : January 3, 2022
Sponsor:
Collaborator:
České Budějovice Hospital
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:
With all of the gains that have been achieved with endovascular mechanical thrombectomy revascularization and intravenous thrombolysis logistics, there is still a subgroup of patients with salvageable brain tissue for whom persistent emergent large vessel occlusion (ELVO) portends a catastrophic outcome. Study aims to test the safety and efficacy of emergent microsurgical intervention in acute ischemic stroke patients with symptomatic middle cerebral artery occlusion after failure of mechanical thrombectomy.

Condition or disease Intervention/treatment Phase
Acute Stroke Surgical Procedure Procedure: Microsurgical intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: case-control
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Emergent Microsurgical Intervention in Acute Stroke Patients After Mechanical Thrombectomy Failure Trial
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Microsurgical intervention
Microsurgical intervention will be used for treatment of acute symptomatic occlusion of middle cerebral artery (in M1 or M2 segment) with or without intracranial ICA occlusion in patients who failed to reach recanalization using standard treatment
Procedure: Microsurgical intervention
The EC-IC bypass distal to the occlusion will be prepared in patients with a failure to pass the lesion using microwire and subjects with a failure to reach the occlusion. Middle cerebral artery exploration and eventual embolectomy will be performed before the bypass. A transverse arteriotomy will be used in the M1 segment occlusion, while a longitudinal arteriotomy with optional subsequent lesion retrieval using a Fogarty catheter will be used in the upper or lower M2 trunk occlusions. Minimally invasive and rapid surgical embolectomy technique will be used in cases with atrial fibrillation as the suspected source of emboli. In cases with successful passage using a microwire or catheter, but with failure of thrombus retrieval, a calcified cerebral embolus can be an example of failure. In cases with suspected occlusion due to intracranial atherosclerosis, the superior temporal artery will be always dissected and EC-IC bypass was performed.

No Intervention: Standard treatment
Acute symptomatic occlusion of middle cerebral artery (in M1 or M2 segment) with or without intracranial ICA occlusion in patients who failed to reach recanalization using standard treatment - intravenous thrombolysis and/or mechanical thrombectomy



Primary Outcome Measures :
  1. Clinical status at 3 month measured using modified Rankin score [ Time Frame: 90 days after randomization ]
    modified Rankin score range: 0-6; favourable clinical outcome: modified Rankin score 0-2; percentage of patients with favourable clinical outcome


Secondary Outcome Measures :
  1. Clinical status at 24 hours measured using modified Rankin score [ Time Frame: 24 hours after randomization ]
    modified Rankin score range: 0-6; favourable clinical outcome: modified Rankin score 0-2; percentage of patients with favourable clinical outcome

  2. Percentage of patients with symptomatic intracerebral hemorrhage [ Time Frame: 24 hours after randomization ]
    Symptomatic intracerebral hemorrhage detected on control CT 24 hours after randomization

  3. Mortality [ Time Frame: 90 days after randomization ]
    Death within 3 month after randomization



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

Inclusion Criteria:

  • age of ≥ 18 years;
  • indication for MT according to valid guidelines;
  • modified Rankin score (mRS) of ≤ 2 before stroke onset;
  • baseline Alberta Stroke Program Early CT Score (ASPECTS) of ≥ 6;
  • MCA occlusion in M1 or M2 segment with or without intracranial ICA occlusion;
  • estimated onset-to-skin cut time of ≤6 h or core/penumbra mismatch in cases with wake-up stroke or stroke with unknown onset;
  • MT failure with TICI score of 0-1 declared by an interventional neuroradiologist and expectation to achieve recanalization within 24 h from stroke onset.

Exclusion Criteria:

  • indication for MT according to valid guidelines;
  • thrombocyte count of ≤ 100,000/µL;
  • contraindication for general anesthesia

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): NCT05153642


Contacts
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Contact: Martin Roubec, MD, PhD martin.roubec@fno.cz
Contact: David Školoudík, Prof MD PhD skoloudik@hotmail.com

Locations
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Czechia
University Hospital Ostrava Recruiting
Ostrava-Poruba, Czech Republic, Czechia, 708 52
Contact: Martin Roubec, MD, Ph.D.       martin.roubec@fno.cz   
Contact: David Školoudík, Prof MD PhD       skoloudik@hotmail.com   
České Budějovice Hospital Recruiting
České Budějovice, Czechia, 37001
Contact: Jiří Fiedler, MD, PhD         
Sponsors and Collaborators
University Hospital Ostrava
České Budějovice Hospital
Investigators
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Principal Investigator: Jiří Fiedler, MD, PhD České Budějovice Hospital
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT05153642    
Other Study ID Numbers: 109/17
First Posted: December 10, 2021    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Free online access to the individual participant data
Supporting Materials: Study Protocol
Time Frame: 1 month after finalizing the study data for 1 year
Access Criteria: No limitation
URL: http://fno.cz

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases