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

NCT05153642 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-01-03

No results posted yet for this study

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.

Conditions

  • Acute Stroke
  • Surgical Procedure

Interventions

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.

Sponsors & Collaborators

  • České Budějovice Hospital

    collaborator OTHER

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Jiří Fiedler, MD, PhD · České Budějovice Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153642 on ClinicalTrials.gov