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

NCT05153642 | Unknown

• 1 other identifier: 109/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Stroke; Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• Clinical status at 3 month measured using modified Rankin score

  modified Rankin score range: 0-6; favourable clinical outcome: modified Rankin score 0-2; percentage of patients with favourable clinical outcome

  90 days after randomization

Secondary Outcomes (3)

• Clinical status at 24 hours measured using modified Rankin score

  24 hours after randomization

• Percentage of patients with symptomatic intracerebral hemorrhage

  24 hours after randomization

• Mortality

  90 days after randomization

Study Arms (2)

Microsurgical intervention

EXPERIMENTAL

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

Standard treatment

NO INTERVENTION

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

Interventions

Microsurgical intervention PROCEDURE

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.

Microsurgical intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• České Budějovice Hospital: collaborator

Study Sites (2)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

RECRUITING

České Budějovice Hospital

České Budějovice, 37001, Czechia

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiří Fiedler, MD, PhD

  České Budějovice Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Roubec, MD, PhD

CONTACT

martin.roubec@fno.cz

David Školoudík, Prof MD PhD

CONTACT

skoloudik@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case-control

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 month after finalizing the study data for 1 year
• Access Criteria: No limitation

Locations

CZ (2)