Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window (AIS)

September 5, 2020 updated by: Eman M. Khedr, Assiut University

Mechanical Thrombectomy in Acute Ischemic Stroke Beyond the Time of Window: Non Randomized Controlled Clinical Trial

Background: intravenous alteplase appears to be much less effective at opening proximal occlusions of the major intracranial arteries, which account for more than one third of cases of acute anterior-circulation stroke and expanding time window using mechanical thrombectomy can improve clinical outcome in patients that would have only received conservative treatment.

The aim of this work is to evaluate the effectiveness of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy with the standard medical therapy at the end of 3rd month follow up.

Material and Methods 57 subjects presenting with an acute ischemic stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery ( ICA segment) within 24 hours from symptom onset as documented by Ct, and or MRI perfusion were recruited consecutively from 2 University hospitals Ain shams University Hospital (32 Patients) and Aswan University (25 patients). Assessment of each subject was performed using NIHSS, and MRS, Aspect score, before intervention. Follow up was done using the same clinical scale one week and the 3 month after the onset.

Primary outcome NIHSS and MRS at the end of 3 month after the onset. secondary outcome complications (cerebral Hge) and death at 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Expanding time window using the emerging technologies for mechanical thrombectomy can improve chances of achieving successful thrombectomy and improve clinical outcome in patients that would have only received conservative treatment. The aim of this work is to evaluate the effectiveness and safety of endovascular therapy within 24 hours of symptom onset and to compare clinical outcome of endovascular therapy and standard medical therapy at the end of 3rd month.

Subjects and Methods:

This is a multicenteric case-control clinical trial (Ain shams and Aswan university hospitals), comparing clinical improvement and mortality/morbidity in patients presenting with acute ischemic stroke stroke caused by occlusion of the proximal middle cerebral artery (M1 segment) or Internal carotid artery (distal ICA segment) within 24 hours from symptom onset.

Onset of stroke was defined as time they were last known to be well. Ischemic stroke is characterized by the sudden loss of blood circulation to an area of the brain, resulting in a corresponding loss of neurologic function. It included 57 patients with acute ischemic stroke due to large vessel occlusion (LVO) admitted either to neurology department of Ain shams university hospitals or Aswan university hospitals between during the period from Jan 2019 and August 2019

All patients were subjected to the following:

A) Clinical assessment:

Full history taking with special emphasis upon: Age and Sex of the patient, onset of symptoms; onset is defined as the point in time the patient was last seen well, presence of vascular risk factors, namely: diabetes mellitus, hypertension, cardiac diseases, dyslipidemia and smoking. History of receiving drugs prior to arrival to the hospital, especially anti-coagulants, and anti-platelets & IV thrombolytics.

Complete general and neurological assessment including: complete general examination including blood pressure measurement using mercurial sphygmomanometer and random blood sugar assessment, neurological examination on admission with NIHSS assessment to determine initial NIHSS, neurological deficit was measured using (NIHSS) obtained on discharge and on day 90 with the modified Rankin Scale (mRS) measured on discharge and after 3 months (Bonita and Beaglehole, 1988). A standard 12-lead ECG to delineate presence of ischemic changes or arrhythmias was also done Routine ER laboratory investigations including: complete blood count and coagulation profile and serum urea and creatinine.

Hypertension was defined as self-report of hypertension with antihypertensive medication use, and/or systolic blood pressure greater than or equal to 140 mm Hg, and/or diastolic blood pressure greater than or equal to 90 mm Hg. Diabetes was defined as being on treatment for diabetes by self-report with antidiabetic drugs and/or having a fasting glucose level greater than or equal to 126 mg/dL, plasma glucose ≥ 200 mg/dl 2 h after a 75-g oral glucose load as in a glucose tolerance test, or glycated hemoglobin (HbA1C) ≥ 6.5%. Patients with past or current history of smoking were categorized as smokers. Dyslipidemia was defined as serum total cholesterol (TC) > 240, serum LDL-c > 160, serum triglycerides (TAG) > 200 and/or serum HDL-c < 40 (WHO 2006).

B) Radiological assessment:

Early ischemic changes and collateral circulation were assessed with the Alberta stroke program for early computed tomography (CT) ischemic score (ASPECTS) and with computed tomography angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) for localization of the LVO.

N.B: a CT scan was routinely performed between 24 and 36 h after treatment or before in case of any neurological worsening (≥4-point increase in NIHSS score) occurred.

Procedure of endovascular intervention:

All patients in the 1st group (vascular intervention group) underwent primary thrombectomy with either the Trevo (TR) stent or the Solitaire (ST) stent (according to the availability) within the first 24 hours of symptoms onset.

All procedures were performed under the investigator's institutional mild sedation protocol. Some cases needed general anesthesia.

Favorable outcome was defined as achieving functional independence "mRS of 0,1or 2 in 3 months, poor outcome was defined as mRS of 3-5. Treatment starting is defined as femoral puncture.

Vascular recanalization was defined as thrombolysis in cerebral ischemia (TICI) score. Successful recanalization was defined as TICI grade 2b to 3.

Established device-related complications, namely, vascular perforation, arterial dissection, or embolization, were systematically collected. Symptomatic intracranial hemorrhage was defined as a hemorrhagic transformation on the 24-h computed tomography (CT) scan related to the deterioration in the patient's clinical condition in the judgment of the clinical investigator.Statistical analysis:

Statistical analysis was performed using the Statistical Package for the Social Sciences (IBM SPSS statistics V23).

Adjusted for age group (1=<70, 2= ≤70 years), Sex (female=0 or male=1), Diabetes mellitus (yes=1 or no=0), Hypertension (yes=1 or no=0),Cardiac (AF=1, IHD=2, Rheumatic heart=3, normal =4, AF +IHD =5) Smoking (yes=1 or no=0), Dyslipidemia (yes=1 or no=0), (B, correlation coefficient; CI, confidence interval; OR, odds ratio; SE, standard error; Wald statistics for logistic regression analysis.

The outcome of interest was the change in NIHSS and mRS scores throughout 90 days. Continuous variables are expressed as mean + standard deviation and categorical variables with percentage of occurrence. For comparison of continuous variables, the Mann-Whitney test was used between-group comparison. Chi Square test was used for analysis of proportions. A p Value <0.05 was the threshold for statistical significance.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo, Egypt
      • Cairo, Cairo, Egypt, Egypt
        • Ahmed El-Bassiony
    • Select State/Province
      • Aswan, Select State/Province, Egypt, 11577
        • Abdalla Khalil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Patients Aged between 18 and 80 years old.
  2. Patients with acute ischemic stroke due to occlusion of the MCA or ICA suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram.

4. Patients with symptoms onset between 6- 24 hours from arrival to the time of femoral puncture.

Exclusion criteria

A. Clinical exclusion criteria:

  1. Patients known to have hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 2.0.
  2. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological evaluations; mRS score before the onset of stroke must be ≤ 1.

B. Neuroimaging exclusion criteria:

  1. Patients with hypodensity on CT accounting to an ASPECTS score of <7.
  2. Patients with CT or MRI evidence of hemorrhage (the presence of micro-bleeds is allowed).
  3. Patients Significant mass effect with midline shift on CT brain.
  4. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) on CT brain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
it included 32 patients with acute ischemic stroke beyond the time of window (more than 6 hours) assigned to mechanical thrombectomy) plus the conventional treatment (Aspirin 150 mg and atorvastatin 40 mg).
Device: thrombectomy
Transfemoral a microcatheter with its distal end was positioned a few millimeters beyond the distal aspect of the clot, the guide wire was exchanged by Solitaire stent device. The device was held in place when 3 mm was out of the microcatheter. The microcatheter was slowly pulled back to deploy the TR or ST device over the clot.
Other: non-intervention group
it included 25 patients with acute ischemic stroke beyond the time of window (more than 6 hours) who received medical treatment (Aspirin 150 mg and atorvastatin 40 mg).
Other: non intervention group
medical treatment (Asprin, statin, nootropic drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Measuring the Modified Rankin Score (MRS) on day 90
Time Frame: 3 months
1- Measuring the Modified Rankin Score (MRS) on day 90 (ranging from, 0 to 6, with higher scores indicating greater disability). Favorable outcome was defined as achieving functional independence (mRS of 0,1or 2) poor outcome was defined as MRS of 3-5.
3 months
2- Measuring the changes in NIHSS on day 90
Time Frame: 3 months
2- Changes in National Institute of Health Stroke Scale (NIHSS) were also measured at baseline (pre-thrombectomy) and on day 90. Favorable outcome when the score decrease by 4 or more point of the score.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Estimate the number and percent of participants who have vascular recanalization
Time Frame: 3 months
1-Estimate the number and percent of patients who have vascular recanalization according to thrombolysis in cerebral ischemia (TICI) score. TICI categories span from no perfusion (grade 0) to complete perfusion (grade 3). The "partial perfusion" category (grade 2) is defined as cases in which contrast passes the obstruction but with rates of entry and wash-out slower than normal and is subdivided into 2 subcategories, 2a and 2b. Successful vascular recanalization was defined as TICI grade 2b to 3.
3 months
2- Estimate the number of participants who developed complications
Time Frame: 3 months
2-estimate the number of patients who developed complication death (mRS=6) symptomatic intracerebral hemorrhage, and arterial dissection.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Ain Shams University
Aswan University Hospital

Investigators

  • Principal Investigator: Eman M Khedr, Professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 20, 2019

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 5, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M thrombectomy in late AIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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