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Endovascular Stroke Treatment Only (ESTO) Trial

NCT04240470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-01-10

No results posted yet for this study

Summary

The specific aims of this study are to:

1. Determine whether the endovascular treatment (mechanical thrombectomy) alone without using intravenous (IV) recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients demonstrates "promise" or a lack thereof ("futility") in deciding what would be the next phase III trial.
2. Determine the proportion of subjects with slight or no disability (a modified Rankin score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA and compare with historical controls who were treated with IV rt-PA to identify (or lack of) futility.
3. Determine the proportion of subjects with improvement in the National Institutes of Health Stroke Scale (NIHSS) score of ≥8 points or achieving a score of 0-1 at 24 hours after the onset of stroke among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
4. Determine the proportion of subjects with angiographic recanalization on post procedure angiogram according to modified Thrombolysis in Cerebral Infarction (TICI) perfusion flow categories among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
5. Determine the proportion of subjects with treatment-related serious adverse events (SAEs) within 72 hours and development of symptomatic intracranial hemorrhage at 27 ±3hrs post treatment among subjects with acute ischemic stroke after receiving endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.

Conditions

  • Acute Ischemic Stroke

Interventions

PROCEDURE

Thrombectomy

Participants will receive endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.

Sponsors & Collaborators

  • Eskisehir Osmangazi University Training and Research Hospital

    collaborator UNKNOWN

  • Kartal Dr. Lütfi Kirdar City Hospital

    collaborator UNKNOWN

  • Sakarya University Training and Research Hospital

    collaborator UNKNOWN

  • Ondokuz Mayis University Training and Research Hospital

    collaborator UNKNOWN

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Adnan Qureshi · University of Missouri-Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-10-23
Completion
2021-10-23

Countries

  • United States

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 NCT04240470 on ClinicalTrials.gov