Endovascular Stroke Treatment Only (ESTO) Trial

NCT04240470 | Completed

• 1 other identifier: 2019141
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are to:

1. 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. 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. 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. 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. 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

Keywords

acute ischemic stroke; endovascular treatment; recombinant tissue plasminogen activator; mechanical thrombectomy

Outcome Measures

Primary Outcomes (1)

• Favorable Outcome

  Modified Rankin Scale (mRS) score of 0-2: 0, No symptoms at all; 1, No significant disability despite symptoms; able to carry out all usual duties and activities; 2, Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. The modified Rankin Scale score ranges from 0, indicating no symptoms, to 6, indicating death.

  90 days

Secondary Outcomes (4)

• Angiographic Recanalization

  Within 6 hours of interventional treatment

• Early Neurological Improvement

  24 hours post enrollment

• Quality of Life Status Using Standardized EQ-5D-3L (EuroQol Five Dimension, Three-Level) Questionnaire.

  90 days

• Quality of Life Status Using EQ VAS (EuroQol Visual Analog Scale) Scores.

  90 days

Other Outcomes (2)

• Treatment-Related Serious Adverse Events

  Within 72 hours of interventional treatment

• Symptomatic intracranial hemorrhage

  24 ± 3hrs post enrollment

Study Arms (1)

Thrombectomy

EXPERIMENTAL

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

Procedure: Thrombectomy

Interventions

Thrombectomy PROCEDURE

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

Thrombectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 through 90 years (i.e., candidates must have had their 18th birthday, but not had their 91st birthday).
• Symptom onset within 4.5 hours of onset of stroke symptoms. Time of onset is defined as the last time when the patient was witnessed to be at baseline (i.e., subjects who have stroke symptoms upon awakening will be considered to have their onset at beginning of sleep).
• An NIHSS ≥ 6 at the time of evaluation. Thrombolysis in Cerebral Infarction (TICI) 0-1 flow in the intracranial internal carotid artery, M1 or M2 segment of the middle cerebral artery (MCA), or carotid terminus confirmed by Computed Tomography (CT) or magnetic resonance (MR) angiography that is accessible to the stent retriever or suction thrombectomy catheter.
• The procedure can be initiated according to guidelines of AHA/ASA which state that the treatment should be initiated (groin puncture) within 6 hours of symptom onset.

You may not qualify if:

• History of stroke in the past 3 months.
• Previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or ruptured brain arteriovenous malformation.
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
• Severe hypertension at time of treatment; systolic blood pressure \> 185 or diastolic \> 110 mm Hg that cannot be corrected prior to treatment.
• Presumed septic embolus.
• Major surgery within the previous 14 days.
• Recent (within 90 days) severe head trauma or head trauma with loss of consciousness.
• Gastrointestinal malignancy or gastrointestinal hemorrhage within 21 days.
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; or oral anticoagulant therapy with International Normalized Ratio (INR) \> 1.7 or institutionally equivalent prothrombin time or platelets count \<100,000 per microliter.
• Women of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
• Patients with renal failure that require hemodialysis or peritoneal dialysis.
• Low molecular weight heparins (such as Dalteparin, Enoxaparin, Tinzaparin, Fondaparinux) as deep vein thrombosis (DVT) prophylaxis or in full dose within the last 24 hours from screening unless anti-activated factor X (anti-factor Xa) assay less than 200% of control value.
• Patients who have received heparin within 48 hours must have a normal partial thromboplastin time (PTT) to be eligible.
• Patients who have received heparin or a direct thrombin inhibitor (Angiomax, Argatroban, Refludan) must have a normal PTT to be eligible.
• Patients on dabigatran etexilate mesylate (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), and edoxaban (Savaysa) may be considered after 48 hours after last intake of medication in patients with normal renal function (CrCl \> 60 mL/minute). If moderate renal impairment, CrCl of 30-59 mL/minute, last dose should be 72 hours before procedure and 96 hours in severe renal impaired patients (CrCl of 15-29 mL/minute). The time interval between the last dose administration and the neurointerventional procedure appears to be the most reliable criterion for assessing the risk of bleeding events. Patients in whom time of last dose ingestion is unknown or within last 48 hours, can be included under following circumstances: normal PTT for dabigatran, normal prothrombin time for rivaroxaban, or anti-activated factor X (anti-factor Xa) assay rivaroxaban (Xarelto), apixaban (Eliquis), or edoxaban (Savaysa) less than 200% of control value.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Eskisehir Osmangazi University Training and Research Hospital: collaborator
• Kartal Dr. Lütfi Kirdar City Hospital: collaborator
• Sakarya University Training and Research Hospital: collaborator
• Ondokuz Mayis University Training and Research Hospital: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Adnan Qureshi

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: Participants will be assigned to receive endovascular treatment for acute ischemic stroke (mechanical thrombectomy) alone without using IV rt-PA.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 27, 2020
• Study Start: September 1, 2020
• Primary Completion: October 23, 2021
• Study Completion: October 23, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)